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What are Compendial Methods?

Compendial methods are standardized methods (protocols) from US Pharmacopoeia (USP). Compendial tests are performed to determine if the pre-set sepcifications are met and/or to address anticipated regulatory concerns. Compendial methods are not required to be fully validated but these methods must be verified to demonstrate the suitability of laboratories to successfully run the method. Also, when methods are transferred between laboratories, successful transfer should be demonstrated through testing or a transfer waiver, if justified. If a laboratory uses an alternative method, instead of a compendial method, equivalency or superiority of the alternative method should be demonstrated. Compendial methods may be implemented as part of the routine quality control strategies, in addition to addressing anticipated regulatory concerns, and/or establishing general drug compatibility.

What are Compendial Methods?
Compendial Methods applicable for Biologics
Compendial Methods applicable for Biologics
01
Appearance
Appearance

visual inspection to ensure products are free of visible particulates

02
Clarity
Clarity

a liquid is considered clear if its clarity is the same as that of water - Ph.Eur. 2.2.1

03
Osmolality
Osmolality

USP <785>

04
pH
pH

USP <791>

05
Bacterial Endotoxins
Bacterial Endotoxins

USP <85>

06
Bioburden
Bioburden

Ph. Eur. 2.6.12

Highlights of our Compendial Methods Services

Our compendial methods release testing solutions support a variety of biologics, biosimilars, combination products, innovative and novel products. All compendial methods-based testing is performed per cGMP standards of 21 CFR 210 and CFR 211.

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Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey 08512, USA
bd_global@crystalpharmatech.com +1-609-604-8303