Ongoing procedure performance verification (OPPV) of an analytical procedure is the process of ensuring it continues to meet its intended use after completion of validation. On the basis of previous studies, this paper further discussed the indicators of ongoing procedure performance verification (including system suitability indicators and reported values, etc.) and the implementation of analysis tools (control charts), and demonstrated the specific operation steps of ongoing procedure performance verification with examples. It is hoped that this paper will provide new ideas for the accurate and standardized procedure verification in the pharmaceutical field, especially in the enterprises and regulatory departments.

Objective: To establish an HPLC method of the content and related substances of compound amino acid injection(3AA). Methods: RP-HPLC was adopted to determine compound amino acid injection(3AA), combining with the use of two-dimensional column switching-LC/MSⁿ method was applied to separate and identify the impurities. The determination was performed on Capcell PAK AQ C₁₈(250 mm×4.6 mm, 3 μm) column with 0.2 mol·L^-1 sodium dihydrogen phosphate solution (adjusted pH to 2.8 with phosphoric acid) -acetonitrile (98∶2) as mobile phase at the flow rate of 1.0 mL·min^-1. The column temperature was 40 ℃, and the detection wavelength was 210 nm. And the injection volume was 20 μL. The LC/MSⁿ method was performed on a Thermo Accucore AQ C₁₈ (100 mm×4.6 mm, 2.6 μm) column with 0.1% formic acid solution as mobile phase A, 0.1% formic acid solution-acetonitrile as mobile phase B, at a flow rate of 0.4 mL·min^-1, and at a column temperature of 40 ℃. The mass spectrometry conditions were performed using an ESI ionisation source in the positive-ion scanning mode with a scan range of m/z 100-1 000, and the secondary mass spectrum was carried out by data-dependent scanning. Results: The related substances were completely separated from the main constituents in RP-HPLC. The standard curve of valine was linear over the range of 1.263-5.050 mg·mL^-1, with the average recovery of 99.0% (n=9). The standard curve of isoleucine was linear over the range of 1.350-5.402 mg·mL^-1, with the average recovery of 99.4%(n=9). The standard curve of leucine was linear over the range of 1.647-6.588 mg·mL^-1, with the average recovery of 99.5%(n=9). The main impurities in the three batches of samples were all process impurities introduced from the raw materials, with methionine content of 4.344 μg·mL^-1, 3.751 μg·mL^-1, 4.503 μg·mL^-1, respectively, phenylalanine content of 4.636 μg·mL^-1, 4.889 μg·mL^-1, 4.753 μg·mL^-1, respectively. The maximum single impurity contents were 0.01%, 0.02% and 0.01%, respectively. Conclusion: The method is proved by the methodology validation that it can be used for the quality control of compound amino acid injection(3AA).

Bioassays play a key role in the development and quality control of biological products, and the research on them has also made great progress in recent years. Here, the historical process of bioassays was reviewed. Then- the current contents about bioassays in pharmacopoeia and technical guidelines weresorted out. At last, the latest progress related to bioassays was summarized and analyzed including the introduction of new concepts such as analytical procedure, method life cycle and analytical target profile.This paper might provide a systematical reference for the people work in the biopharmaceutical field to fully understand the bioassays and related guidelines. Meanwhile, it can also provide a theoretical support for drug researchers to establish scientific and reliable bioassays.

Objective: To compare the quality of wild and cultivated Arnebiae Radix,using macroscopic investigation and chemometric analysis of the different components in wild and cultivated Arnebiae Radix from three different habitats. Methods: Wild and cultivated Arnebiae Radix were collected and their macroscopic features were compared. Using the ACQUITY UPLC BEH C₁₈ (2.1 mm×100 mm, 1.7 μm) column, with acetonitrile-0.05% formic acid water as the mobile phase, the contents of D-shikonin, acetylshikonin, β-acetoxyisovalerylshikonin, isobutyrylshikonin, β,β’-dimethylacrylalkannin and isovalerylshikonin in 48 batches of wild and cultivated Arnebiae Radix were determined. The detection wavelength was 275 nm and the flow rate was 0.2 mL·min^-1. PCA and OPLS-DA were performed to reveal the differential components of wild and cultivated Arnebiae Radix. Results: There were great differences in macroscopic features of wild and cultivated Arnebiae Radix, and the linear relationship between the contents of six naphthoquinone components was good. The correlation coefficients were above 0.999, the average recovery rates were 93.4%-102.9%, and the RSDs were less than 3.0%. The contents of six components in different batches of wild and cultivated Arnebiae Radix were quite different, and the contents of D-shikonin and acetylshikonin in wild products were significantly higher than those in cultivated products, indicating that there were still certain differences between wild products and cultivated products. The PCA model established could distinguish wild products and cultivars, and two differentiating components in wild products and cultivars were revealed by OPLS-DA, namely isobutyryl shikonin, β,β’-dimethylacrylalkannin. Conclusion: By comparing the core size, cork curl degree and specific odor of wild and cultivated products, the two can be identified. The established content determination method is repeatable, specific, stable and feasible. The differential components in wild and cultivated Arnebiae Radix in three different regions are identified, which provides a basis for the quality control of Arnebiae Radix and provides ideas for expanding the source of Arnebiae Radix.

The change of analytical procedure, a part of the entire lifecycle of a method, is increasingly valued with the emergence of new technologies, the increasing demand for product quality, 3R, environmental protection, and cost reduction requirements. This paper refers to the latest progress in the study of counterpart law at home and abroad, systematically classifies changes of analytical procedures from the perspective of methodology, and discusses the differences between different types of changes and the evaluation criteria and implementation approaches of analytical procedures after procedure changes.

Liposome is a drug delivery system which has been successfully transformed for clinical application. In the past few decades, liposome as a drug delivery system has been extensively and deeply studied in the field of therapy. A variety of liposome drugs have been marketed at home and abroad, but there are few reports on the systematic quality detection and evaluation methods. In this paper, the preparation technology and systematic quality evaluation methods of liposome drugs were reviewed based on domestic and foreign literature and relevant technical guidelines, so as to provide reference for the development and evaluation of liposome drug delivery technology.

Growth hormone is a protein hormone with a single peptide chain produced and released by the anterior pituitary, which is the most important hormone for growth promotion after birth. In order to exert biological effects, growth hormone first binds to a specific receptor on the cell surface, and then activates the down stream signaling pathways of the non-receptor tyrosine kinase JAK2 and Src family kinases. An in-depth understanding of the mechanism of action of growth hormone is required for its biological activity measurement. In this paper, we reviewed the recent research progress on growth hormone, including the mechanism of action of growth hormone receptor, the activation of STATs, PI3K-Akt and MEK-Erk signaling pathways by the binding of growth hormone to the receptor, and the regulatory mechanism of growth hormone action pathways. We also summarized and prospected the research on the determination methods of growth hormone activity, in order to provide a reference for the quality control of the biological activity of growth hormone drugs.

Objective: To establish an ultra-high performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) for the simultaneous determination of daidzein, formononetin, genkwanin, quercetin, rutin, apigenin, kaempferol, luteolin and puerarin in Tongfu Jingyaotong tincture. Methods: The Waters ACQUITY UPLC HSS T3 Column (100 mm×2.1 mm,1.8 μm) was used with methanol and 0.1% formic acid (gradient elution) as the mobile phase at a flow rate of 0.3 mL·min^-1. Column temperature was 45 ℃, and injection volume was 2.0 μL. Electrospray ion source was adopted with positive and negative ion modes and multi-reaction monitoring and acquisition. Results: Apigenin, genkwanin and daidzein had good linearity in the range of 0.2-1 000 ng·mL^-1, puerarin, rutin, luteolin, kaempferol and formononetin in the range of 0.2-2 000 ng·mL^-1, and quercetin in the range of 1.0-5 000 ng·mL^-1. The resolution was good, and the RSDs of precision, repeatability, reproducibility and stability test were all below 5% (n=6). The average recoveries ranged from 82.7% to 111.8% with RSDs (n=6) of 2.0%-5.4%. The contents of daidzein, formononetin, genkwanin, quercetin, rutin, apigenin, kaempferol, luteolin and puerarin in 6 batches of Tongfu Jingyaotong tincture were 8.46-17.97 μg·mL^-1, 0.62-1.67 μg·mL^-1, 0.03-0.08 μg·mL^-1, 1.34-2.22 μg·mL^-1, 0.70-1.14 μg·mL^-1, 0.48-0.99 μg·mL^-1, 0.20-0.90 μg·mL^-1, 0.10-0.16 μg·mL^-1 and 167.95-227.75 μg·mL^-1, respectively. Conclusion: This method has strong specificity, wide linear range, accuracy and efficiency, and can detect the contents of 9 active ingredients in Tongfu Jingyaotong tincture at the same time, which offers an effective quality control method for Tongfu Jingyaotong tincture.

Objective: To establish an innovative analytical method based on high resolution sampling two-dimensional chromatography (HiRes 2D-LC) for determination of the content of vitamin D₃ in vitamin D drops. Methods: Two-dimensional liquid chromatography was used. Thermo HYPERSIL Gold Silica (100 mm×2.1 mm, 1.9 μm) column was used in the first dimension with n-hexane-n-amyl alcohol (996∶4) as mobile phase. The flow rate was 0.2 mL·min^-1. The samples were injected and tested at the wavelength of 265 nm. The column temperature was 40 ℃. In the second dimension liquid chromatography, ShimPack Velox Hilic (50 mm×2.1 mm, 2.7 μm) was used as the column with n-hexane-n-pentanol-isopropanol (98∶1∶1) as the mobile phase. The flow rate was 0.5 mL·min^-1. The samples were injected and tested at the wavelength of 265 nm. The column temperature was 40 ℃. A six-position 14-way valve and was equipped with 2 multi-center cutting valves was equipped to make multiple consecutive cuts of the pre-vitamin D₃ peak and vitamin D₃ peak. Results: The calibration curves showed a good linearity at the range of 1.018 4-5.092 mg·mL^-1(r≥0.999 8). The precision test showed the RSDs of the peak area of pre-vitamin D₃ and vitamin D₃ were 0.95% and 0.40%, respectively. The repeatability test showed the RSD of vitamin D₃ content was 0.41%. The average recovery rate (n=9) was 101.4%. The test solution was stable at 4 ℃ and 10 ℃ for 12 h, and the RSDs were 0.58% and 0.66%, respectively. The contents of vitamin D₃ in the samples of vitamin D drops measured by this method were 100.4%, 101.6%, 100.9%, 101.6%, 102.7% and 101.6%, which was basically consistent with the results measured by the fourth method in General Chapter 0722 of ChP 2020 Vol Ⅳ. Conclusion: This method has a good specificity and high sensitivity to accurately determine the content of vitamin D₃ in vitamin D drops.

Scientific design of experiment (DOE) is the main tool to ensure the accuracy of test results and the reliability of conclusions. It is discussed the validation design for bioassay with many influencing factors and great variation, and the calculation method of sample size in method validation design is elaborated in detail here. It is hoped that it could provide theoretical reference for bioassay valiadation to accurately understand the experimental design of method validation.

Objective: To establish an HPLC characteristic chromatogram of Xifeng Huoluo capsules, and to determine the contents of gastrodin, amygdalin, strychnine, hydroxysafflower yellow A, brucine, paeoniflorin, ferulic acid, salvianolic acid B, cryptotanshinone, tanshinone Ⅰ, and tanshinone ⅡA. Methods: Extraction of 75% methanol was analyzed by a Venusil MP C₁₈ chromatographic column (250 mm×4.6 mm, 5 μm) using 0.1% phosphoric acid (A) -acetonitrile (B) as the mobile phase with gradient elution at a flow rate of 1.0 mL·min^-1. The column temperature was 30 ℃. The detection wavelengths were variable. The characteristic chromatograms of 10 batches of Xifeng Huoluo capsules were evaluated by similarity evaluation, and the eleven identified index components were quantitatively determined. Results: There were thirty-one common peaks in the characteristic chromatograms of eleven batches of samples and the similarities were all above 0.99. The common peaks could ascribed to twelve medicinal materials, and eleven of them were identified. Eleven components showed good linearity within their respective ranges (r≥0.999 4), and the average recoveries were 99.3%-103.0% with RSDs of 1.5%-2.4%. Conclusion: The established method has high sensitivity and strong specificity. The HPLC characteristic chromatogram combined with multi-component quantitative determination can fully reflect its inherent quality and can be used for the quality control of Xifeng Huoluo Capsules.

Objective: To establish the RP-UPLC-PDA method for simultaneous determination of triptolide, triptonide, triptophenolide, wilforine, wilforlide A and celastrol in Tripterygii Radix. Methods: Tripterygii Radix were extracted with ethyl acetate and the extracts were dissolved and separated by methanol. The six components were determined by RP-UPLC-PDA method. The chromatographic column was Acquity^TM UPLC BEH C₁₈ column (100 mm×2.1 mm, 1.7 μm), the column temperature was 30 ℃, the injection volumn was 2 μL, the flow rate was 0.4 mL·min^-1 and the mobile phase was acetonitrile (A)-0.1% formic acid (B). Results: The linear relationship of six components was good (0.999 2≤r≤0.999 7) in the concentration ranges. The average recoveries were 99.2%-103.1% and RSDs were 1.2%-2.9%. The contents in 10 batches of Tripterygii Radix from different habitat were determined. The results showed that the contents of Tripterygii Radix in prepared pieces from different producing areas were different. The highest content of triptolide was 140.2 μg·g^-1, and the lowest content was 103.2 μg·g^-1. The highest content of triptonide was 224.7 μg·g^-1 and the lowest content was 112.2 μg·g^-1. The highest content of triptophenolide was 306.7 μg·g^-1 and the lowest content was 189.6 μg·g^-1. The highest and lowest contents of wilforine were 283.2 μg·g^-1 and 211.2 μg·g^-1. The highest content of wilfhabitat was 31.2 μg·g^-1 and the lowest content was 16.8 μg·g^-1. The highest content of celastrol was 87.6 μg·g^-1, and the lowest content was 52.1 μg·g^-1. Conclusion: The RP-UPLC-PDA method can simultaneously determine six components in Tripterygii Radix. The method is reliable and stable, which is suitable for quantitative analysis and determination of Tripterygii Radix.

Objective: To establish a stable and reliable gas chromatography-tandem mass spectrometry method for the determination of N-nitrosodimethylamine (NDMA) in metformin hydrochloride sustained-release tablets, and to optimize extraction conditions by investigating the effects of isopropyl alcohol and thioglycerin on the stability of the tested solution. Methods: Separation was achieved on AB-InoWax capillary column (30 m×0.25 mm×0.25 μm) with polyethylene glycol as the stationary phase. Electron ion(EI) source and multiple reaction monitoring (MRM) mode were used. Quantitative determination was performed by both external standard and internal standard. Results: The addition of thioglycerin could significantly improve the stability of the test solution. NDMA showed good linearity within the concentration range of 0.25-50 ng·mL^-1(r>0.999). The detection limit of the method was 0.1 ng·g^-1 and the quantification limit of the method was 0.2 ng·g^-1. The average recoveries (n=9) were 97.3% and 94.9% while using external standard and internal standard, respectively. Precision, repeatability and stability were good with RSD less than 8%. Ninety batches of metformin hydrochloride sustained release tablets were tested. NDMA content in all detected samples were all less than 30% of the acceptable limit set by the National Medical Products Administration and FDA. Conclusions: This method shows satisfactory sensibility, specificity, accuracy, stability and durability, which is suitable for quantitative analysis of NDMA in metformin hydrochloride sustained-release tablets, providing technical support for the quality and safety of related products.

Objective: To establish a method for related substances determination in timolol maleate by ultra-high performance liquid chromatography-quadrupole/orbitrap high resolution mass spectrometry(UPLC-Q/Orbitrap HRMS), by which the impurities both in active pharmaceutical ingredients(APIs) and preparations can be recognized and determined. Methods: An ACE Excel3 C₁₈-AR column(150 mm×4.6 mm, 3 μm)was used for the separation and a mixture of 0.01 mol·L^-1 ammonium acetate solution with 0.02% formic acid and methanol was employed as the mobile phase by gradient elution, at a flow rate of 0.6 mL·min^-1. The detection wavelength for UV detector was 295 nm, an HESI(heated ESI)ion source was employed in both the positive mode and negative mode. The possible fragmentation patterns prediction was conducted with the help of Mass Frontier 8.0 and Compound Discover 3.3. The related substances could be recognized and determined by means of the forced degradation of the APIs, with the calibration by the correction factors and confirmation by the mass spectrum data from UPLC-Q/Orbitrap HRMS. Results: The timolol impurity B[3-(tert-butylamino)-2-(4-morpholino-1, 2, 5-thiadiazol-3-yloxy)propan-1-ol], timolol impurity D(4-morpholino-1,2,5-thiadiazol-2-ol), timolol impurity E((S,Z)-4-(｛1-(tert-butylamino)- 3-[(4-morpholino-1, 2, 5-thiadiazol-3-yl) oxy] propan-2-yl｝oxy)-4-oxobut-2-enoic acid maleate salt) and timolol impurity C[N-(tert-butyl)-2, 3-bis (4-morphloline-1, 2, 5-thiadiazol-3-yloxy) propan-1-amine maleate] were produced from the APIs under selected conditions and separated well in the specified HPLC condition, the limit of quantitation was 0.05 μg·mL^-1 and the limit of detection was 0.015 μg·mL^-1 for HPLC-UV. The contents of individual impurities were between 0.000 4%-0.09% and the results of total impurities were between 0.02%-0.12% for the samples from 4 different manufactures. The probable chemical structures of the 6 unspecified impurities were speculated according to the fragmentation pattern of fragment ions, combined with the fragment information, chemical structure of API and the references. Conclusion: The system solution can be obtained by the degradation of the API, and be implied in the impurity analysis for the timolol maleate. The results can be used as a reference for the quality control of timolol maletae.

Objective: To analyze and optimize stir-baked with vinegar technology of Genkwa Flos decoction pieces by multi-index weighted scoring method based on orthogonal experiment, and to provide technical index on standardization of stir-baked with vinegar technology of Genkwa Flos decoction pieces. Methods: The orthogonal experiment was employed to analyze and evaluate the four key factors related to stir-baked with vinegar technology including the amount of vinegar, dampening time, temperature and stir-baked time by the six main indicators including the total contents of chlorogenic acid, tiliroside, luteolin, apigenin, hydroxygenkwanin and genkwanin, the content of alcohol extractive and appearance characters. Results: The amount of vinegar and stir-baked temperature had notable effects, while the dampening time and stir-baked time had no notable effects on the test results. Considering comprehensively the effects of four key factors, the optimized stir-baked with vinegar technology was as follows: add 0.3 kg of vinegar to 1 kg of Genkwa Flos, and fry at 160 ℃ for 10 min after dampening for 15 min. Conclusion: This study offers guidance and reference for standardizing the stir-baked with vinegar technology of Genkwa Flos decoction pieces.

Objective: To determine the color of Arnebiae Radix, and the contents of six main purple pigment components (acetylshikonin, β-acetoxyisovalerylalkannin, deoxyshikonin, isobutylshikonin, β, β’-dimethylacrylalkannin and isovalerylshikonin) in Arnebiae Radix, and to study on the correlation between the color of Arnebiae Radix and the contents of six main purple pigment components. Methods: The L, a, and b values of the sample powder were determined using a spectrophotometer to characterize the color of Arnebiae Radix. The International Commission on Illumination (CIE) had developed a Lab color model, which was a digital description of human vision. A higher L value indicated greater brightness, a higher a value indicated redness and a lower a value indicates greenness, and a higher b value indicated yellowing and a lower b value indicates blueness. The contents of purple pigment components were determined using high performance liquid chromatography (HPLC), and the correlation between L, a, and b values and the contents of six main purple pigments was calculated using SPSS software. Results: The contents of acetylshikonin in 135 batches of samples ranged from 0.01% to 3.39%. The contents of β-acetoxyisovalerylalkannin ranged from 0.00% to 1.95%. The contents of deoxyshikonin ranged from 0.00% to 0.23%. The contents of isobutylshikonin ranged from 0.01% to 1.13%. And the contents of isovalerylshikonin ranged from 0.02% to 2.88%. The contents of β, β’-dimethylacrylalkannin ranged from 0.01% to 2.17%. There was a significant negative correlation between the contents of acetylshikonin, β-acetoxyisovalerylalkannin and isobutylshikonin and the L (black_white) chromaticity value of Arnebiae Radix, with a Spearman correlation coefficients between -0.138 and -0.222. The chromaticity value of a (red_green) was related to the five components other than acetylshikonin, which were β-acetoxyisovalerylalkannin, deoxyshikonin, isobutylshikonin, β, β’-dimethylacrylalkannin, and isovalerylshikonin, with a spearman correlation coefficients between 0.176 and 0.355; b (blue_yellow) chromaticity value was related to the five components other than β-acetoxyisovalerylalkannin, which were acetylshikonin, deoxyshikonin, and isobutylshikonin, β, β’-dimethylacrylalkannin. β, β’-dimethylacrylalkannin was positively correlated with a coefficient of 0.290, and negatively correlated with the other four components with a coefficients between -0.325 and -0.633. Conclusion: It is recommended that the assay limits of Arnebiae Radix be revised to β, β’-dimethylacrylalkannin not less than 0.30% and isovalerylshikonin not less than 0.29%.

The whole life cycle study of bioassay is an important content of pharmacology. It is widely used in the fields of drug activity determination, new drug research and physiological activity determination of hormones and neurotransmitters. It still plays an irreplaceable role in the determination of some drugs, especially biochemical drugs. Bioassay is different from other physical and chemical determination methods because of its own characteristics and complicated analysis of statistics. Therefore, this kind of method involves more professional terms, which is prone to be confused in understanding and use. The correct understanding of terms is the fundamental basis for the research work related to bioassay. Therefore, this paper makes a preliminary summary and analysis of some key terms in bioassay (eg. method suitability, replicate, parallelism), in order to be helpful for relevant analysts to carry out bioassay.

Long-acting injectable formulations are preferred over conventional formulations for the treatment of chronic diseases. The regulatory guidelines and pharmacopoeia have remained silent on dissolution methods for long-acting injectable formulations due to their diverse nature. The lack of compendial method for dissolution testing increases the duration of approval process for long-acting injectable formulations. This article reviews various dissolution methods used to study in vitro drug release profile of long-acting injectable formulations. Compendial as well as noncompendial methods, such as-flow-through cell method, sample and separate method, the dialysis method are used by researchers for drug release profile of long-acting injectable formulations. This review article also highlights the advantages and disadvantages of reported dissolution methods. The compiled work will help the researchers in designing the bio-relevant dissolution method and expedite the development of long-acting injectable formulations.

Objective: To explore the definition and systematic taxonomy of bioassay method, to provide ideas for better understanding the essence of bioassay. Methods: According to the attribute characteristics of bioassay, the classification framework of bioassay was established and the meaning for the classification was explained. Results: (1) The definition of bioassay has different emphases, mainly due to the different focus in various fields, but the theme was basically the same. (2)Potency and its derivative terms had their definitive connotations and extents in bioassay, and accurate use of these terms could make the expression more professional and clearer. (3) Bioassays could be classified according to many attributes, such as whether directness or not of the biological effect detected, the type of the biological subsector used for assay, the nature and mechanism of the bioassay, and the data type of reportable value of the bioassay. Conclusion: Accurate and standardized definition and classification of bioassay are not only conducive to the standardization of expression for use, but also provide theoretical basis and technical support for further understanding, application and improvement of bioassay.

Objective: To optimize the content determination method of morphine sulfate suppositories, which had high toxicity of extraction solvent and poor specificity and generality of chromatographic conditions. Methods: The optimization of the preparation method for the test solution was to prepare the test solution by ice bath freezing and n-heptane extraction, and to compare the content determination results of the test solution prepared by the United States Pharmacopeia method (extracted with trichloromethane). The optimization of chromatographic conditions for content determination was based on the comprehensive comparison of United States Pharmacopeia, British Pharmacopeia and YBH specification. Symmetry C₁₈ column (150 mm×4.6 mm, 5 μm) was finally used. The mobile phase was 0.01 mol·L^-1 potassium dihydrogen phosphate solution containing 0.202% sodium heptane sulfonate (containing 0.1% triethylamine, adjusted to pH 2.5 with phosphoric acid) -methanol (70∶30). The flow rate was 1.0 mL·min^-1. The column temperature was 30 ℃. The detection wavelength was 284 nm. The injection volume was 20 μL. Results: The content measured by ice bath freezing method was relatively low, while the content measured by n-heptane extraction and trichloromethane extraction was basically consistent, indicating that n-heptane could be used as extraction solvent instead of halogenated alkane. The linear range of morphine sulfate was 2.12-105.94 μg·mL^-1(r=0.999 9), and the LOQ was 10.60 ng. The RSD values of system precision, repeatability, intermediate precision and stability were all less than 2%. The average recoveries were 98.6%-99.6% and RSD was 0.21%-0.66%. After forced degradation, the main peak of the tested solution could be separated from the degraded impurities, with good specificity. By changing the flow rate, column temperature, pH value, mobile phase ratio and column brand, the main peak could be well separated from each impurity peak, with good robustness. Conclusions: This study optimized the determination method for morphine sulfate suppositories. The preparation of the test solution used n-heptane instead of the highly toxic haloalkane, and meanwhile improved the chromatographic conditions, enhanced the environmental protection, specificity and applicability of the method. It can be used for the content determination of morphine sulfate suppositories.

Objective: To discuss the scientific standardization of the expression of biological potency results. Methods: The suitability assessment, the standardization of the reportable value and the modification of the significant figure were discussed. Results: (1)Accurate and reliable final report value could be obtained only when both system suitability test and sample suitability test of the bioassay was satisfied. (2)The expression of the reportable value should reflect the corresponding precision, usually expressed by using the relative confidence interval of the estimated potency. (3)The significant figure of the reportable value should be determined according to the variability of the bioassay and the relevant modification rules. Conclusion: The discussion on the scientific and standardized expression for reportable value of biological potency has a demonstration effect on titer determination.

Althought mRNA vaccines have been developed for nearly 30 years, but due to certain technical bottlenecks in production, stability, and reactivity, the development of mRNA vaccines has been relatively slow. During the epidemic of COVID-19, mRNA vaccine had been fully verified its effectiveness and safety for preventing infectious diseases. Here, this article summarized the key quality control attributes and related requirements of mRNA vaccine products for preventing infectious diseases by reviewing the quality control guidance documents of WHO and drug regulatory and standardization agencies, aiming to provide reference for the quality control of mRNA vaccine products for preventing infectious diseases in China.

This article focuses on the key experimental operations in the study about the applicability of microbial limit testing methods for drugs, summarizing literature and experience from the preparation of test solution, design of methods for microbial counting and control bacteria inspection, operation of microbial recovery test, bacterial liquid concentration counting, and operational methods for controlling bacterial & fungal purity. Emphasis was placed on the preparation methods of water-soluble test samples with strong antibacterial effects, non-oil and fat test samples that were not easily soluble and dispersed, and the test solution for oil and fat test samples. Detailed introduction of the sequential experimental plan for methods of aerobic bacterial count, mold & yeast count, and control bacterial inspection were introduced. Four operational methods for adding bacteria about membrane filtration were explained, and the impact of different ways of adding bacteria on the results of the method was analyzed. Summarized three counting methods for bacterial & fungal concentrations. Detailed sharing of operational experience on controlling the purity of bacterial solution. Summarized the current status about research on the applicability of microbial limit testing methods of drugs. Four suggestions for the future development of research on the applicability of microbial limit testing methods for drugs have been proposed:(1) Unify the operation about bacteria adding method in membrane filtration,scientific and reasonable;(2)Strengthen supervision of pharmaceutical production enterprises and review of microbial limit testing methods for drugs;(3)Unify the microbial limit testing methods for the drugs of the national sampling plan,and gradually collect and bind into a book;(4)Strengthen the research on the applicability of microbial limit testing methods for excipients.

In recent years, the domestic gene therapy industry has developed rapidly, and innovative gene therapy products are emerging constantly. How to effectively control the quality of such products has become a highly concerned issue in the industry. This article draws inspiration from relatively mature, effective, and practical methods in the field of quality control of gene therapy products. Taking recombinant adeno-associated virus gene therapy products as an example, starting from the selection of testing items and methods, precautions, and formulation of quality standards, it elaborates on their quality control inspection items and related technical requirements. We hope this article can provide reference for practitioners to conduct quality control research on such products, and through subsequent communication and discussion, a certain consensus can be reached, thereby accelerating the development of gene therapy industry in China.

Objective: To establish a hydrogen nuclear magnetic quantitative method which can rapidly determine the contents of linalool and protocatechuate in Homalomena occulta. Methods: Using dimethyl sulfoxide-d₆(DMSO-d₆)as the test solvent and pyrazine -as the internal standard, ¹H-q NMR measurement was performed on a 400 MHz spectrometer. The quantitative resonance peaks of pyrazine, Linalool and protocatechuate were δ 8.66, δ 5.90 and δ 8.60, respectively. Results: The linear correlation coefficients of linalool and protocatechuate were good with r of 0.999 7 and 0.998 6, respectively. The RSDs of precision were 0.30% and 0.40%, and the recoveries were 98.8%-100.7%(RSD=3.7%) and 99.4%-100.6%(RSD=4.4%), respectively, which indicated that the established method was accurate, stable and feasible. And the whole detection process was completed in about three minutes. The contents of 2 components in 4 batches of Homalomena occulta were 0.328-0.398 mg·g^-1(linalool)and 0.559-0.630 mg·g^-1 (protocatechuate), respectively. Conclusion: The ¹H-q NMR method has the advantages of simple operation, fast analysis speed and specificity, and can be used for the simultaneous determination of two active components in Homalomena occulta, providing a scientific basis for the overall quality evaluation and quality control of Homalomena occulta.