IPEC e-newsletter - Excipients Insight March 2018 - 28-03-18

 

Inside this issue

     

ChP publishes general chapter on capsules

On 13 February, the Chinese Pharmacopoeia Commission (ChP) released a revised draft of General Chapter on Capsules (Vacant Capsules) (link in Chinese) for consultation, covering the common technical requirements for capsules used in oral pharmaceutical preparations.

IPEC China has kindly provided an English translation of the new document (which members can obtain via IPEC Europe’s Secretariat), with the introduction noting that the “preparation, in-process control and quality control of vacant capsules should comply with the relevant technical requirements of this general chapter.”

The document covers: general requirements; the classification of vacant capsules; nomenclature; preparation; applicability for dosage forms; stability; and storage, transportation and packaging.

The deadline for comments is 30 April, 2018, according to ChP.

 

 

 

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