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From the 2015 edition to the 2020 edition of Pharmacopoeia, pharmaceutical excipients will finally take a place

Pharmaceutical excipients are additives used in the production of drugs and the formulation of prescriptions. They have the important functions of shaping, acting as carriers, improving stability, solubilizing, assisting dissolution, sustained and controlled release and so on. They account for more than 90% of the drugs and are essential components of drugs. Has an important effect on the quality, safety and effectiveness of drugs. The 2020 edition of Chinese Pharmacopoeia (issued on July 3, 2020 and implemented since December 30, 2020) puts forward new standard requirements for the quality of pharmaceutical excipients on the basis of the 2015 edition of Pharmacopoeia.

 

I. Changes in description.

There are no clear provisions on the quality standards and production management requirements of the existing pre-pharmaceutical excipients, and the industry generally refers to the requirements of drug substances or preparations. In the 2020 edition of the Pharmacopoeia, the word "drug" in part of the ordinary cases in the four parts of the original 2015 edition of the Chinese Pharmacopoeia was changed to "pharmaceutical excipients", which indicates that pharmaceutical excipients have different management requirements and standards from drugs. Such as:

2015 edition

2020 edition

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 results not only have identification significance for drugs, but also reflect the purity of drugs. It is one of the main indicators for evaluating 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 result not only has identification significance, but also reflects the purity of medicinal excipients to a certain extent, which is one of the indicators for quality evaluation.

 

II.Refinement of functional indexes of pharmaceutical excipients

In the guidelines for the study on functional indicators of 9601 pharmaceutical excipients, each type was subdivided into chemical properties, physical properties, functional mechanism and functional related indicators, and the types studied and established for indicators were changed from 12 in the original 2015 edition to 19 in 2020. Different from the 2015 version of the brief introduction.

2015 edition

2020 edition

The examination includes test methods and limits reflecting the safety and effectiveness of drugs, preparation process requirements such as homogeneity and purity; Life in the provisions of the various impurities inspection items, refers to the drug in accordance with the established process for production and normal storage process may contain or produce and need to control the impurities (such as residual solvents, related substances, etc.); When the production process is changed, relevant items shall be additionally considered and revised.

Inspections include those reflecting the physicochemical properties, safety and functional related indicators of pharmaceutical excipients; For a variety of impurities in the provisions of the inspection project, refers to the pharmaceutical excipients in accordance with the established process for production and normal storage process may contain or produce and need to control the impurities (such as residual solvents, related substances, etc.); When the production process is changed, relevant items shall be additionally considered and revised.

 

2015 edition

2020 edition

Diluent, binders, disintegrant, lubricants, glidants and anticaking agents, hollow capsule, coating materials, wetting agents and/or solubilizers, suppository bases, suspending agents and/or thickening agents, ointment bases.

Diluents, binders, disintegrants, lubricants, glidants and anticaking agents, coating agents or plasticizers, surfactants, suppository bases, suspending agents/thickeners, ointment bases, complexing agents (chelating agents, encapsulating agents), humectants, film forming agents, freeze-drying protective agents, dry powder inhaler carriers, emulsifiers, release regulators, pressure-sensitive adhesives, hardeners.

 

III. Guiding principles for the addition of 9602 pharmaceutical excipients of animal origin and for the quality control of 9603 premix and co-process pharmaceutical excipients.

All these have played an extremely important role in the standard quality management of pharmaceutical excipients.

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

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


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