From the 2015 edition to the 2020 edition of the pharmacopoeia, medicinal excipients will eventually occupy a place!

Release time:

2021-07-13 14:53

Pharmaceutical excipients are additives used in the production of drugs and formulation of prescriptions. They have important functions such as shaping, acting as a carrier, improving stability, solubilizing, solubilizing, and slow-controlled release. They account for more than 90% of the proportion of drugs and are essential for drugs. Ingredients. It has an important influence on the quality, safety and effectiveness of drugs. The 2020 edition of the Chinese Pharmacopoeia (released on July 3, 2020 and implemented on December 30, 2020) puts forward new standard requirements for the quality of pharmaceutical excipients on the basis of the 2015 edition of the Pharmacopoeia.

Description of changes

The existing quality standards and production management requirements for former pharmaceutical excipients are not clearly defined, and the industry generally refers to the requirements of APIs or preparations. In the 2020 edition of the Pharmacopoeia, the original 2015 edition of the Chinese Pharmacopoeia four every case part of the word about "drugs" is changed to "pharmaceutical excipients", which shows that pharmaceutical excipients have different management requirements and standards from drugs. Such:

2015 version

2020 version

Physical constants include relative density, distillation range, melting point, condensation point, specific rotation, refractive index, viscosity, absorption coefficient, iodine value, saponification value and acid value, etc. The determination results not only have identification significance for drugs, but also reflect the purity of drugs, which is one of the main indicators to evaluate the quality of drugs.

Physical constants include relative density, distillation range, melting point, condensation point, specific rotation, refractive index, viscosity, absorption coefficient, acid value, hydroxyl value, iodine value, peroxide value and saponification value, etc. The determination results not only have identification significance, but also reflect the purity of pharmaceutical excipients to a certain extent, and are one of the indicators for evaluating quality.

Refinement of Functional Indicators of Pharmaceutical Excipients

In the guiding principles for the study of functional indicators of 9601 pharmaceutical excipients, each type is subdivided into chemical properties, physical properties, functional mechanisms and functional related indicators, and the types of indicators studied and established have also been changed from 12 categories in the original 2015 version to 19 categories in 2020. It is different from the simple introduction of the 2015 version.

2015 version

2020 version

The inspection items include test methods and limits reflecting the safety and effectiveness of drugs, uniformity and purity and other preparation process requirements. Various impurity inspection items ordered in the regulations refer to impurities (such as residual solvents, related substances, etc.) that may be contained or generated and need to be controlled during the production and normal storage of the drug according to the established process; When changing the production process, additional revision of relevant items shall be considered.

The inspection items include the inspection reflecting the physical and chemical properties, safety and functionality of pharmaceutical excipients. For various impurity inspection items in the regulations, it refers to the impurities (such as residual solvents, related substances, etc.) that may be contained or generated and need to be controlled during the production and normal storage of pharmaceutical excipients according to the established process. When changing the production process, additional revision of relevant items shall be considered.

2015 version

2020 version

Diluents, binders, disintegrants, lubricants, glidants and anti-caking agents, hollow capsules, coating materials, wetting and/or solubilizing agents, suppository bases, suspending and/or thickening agents, ointment bases.

Diluents, binders, disintegrants, lubricants, glidants and anti-caking agents, coating agents or plasticizers, surfactants, suppository bases, suspending/thickening agents, ointment bases, complexing agents (chelating agents, encapsulating agents), humectants, film-forming agents, lyophilization protectants, dry powder inhaler carriers, emulsifiers, release modifiers, pressure-sensitive adhesives, hardeners.

New principle

New guidelines for 9602 animal-derived pharmaceutical excipients and guidelines for quality control of 9603 premixed and co-processed pharmaceutical excipients have played an extremely important role in the quality management of pharmaceutical excipients standards.

The improvement of the standards and requirements of pharmaceutical excipients can regulate the behavior of upstream pharmaceutical excipients suppliers and provide a strong guarantee for the safety and effectiveness of drugs.

The quality management of pharmaceutical excipients is becoming more and more strict. For the pharmaceutical industry, this is both an opportunity and a challenge. It is necessary for pharmaceutical excipients manufacturers to continuously improve and standardize relevant standards, continuously improve their own defects and improve overall quality awareness. In order to jointly create a good atmosphere for the pharmaceutical excipients market.

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