ChP StandardsAPI & Excipient
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A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Acacia
CAS: 9000-01-5
Excipient
Acarbose
CAS: 56180-94-0
API
Aceclofenac
CAS: 89796-99-6 
API
Acedapsone
CAS: 77-46-3
API
Aceglutamide
CAS: 2490-97-3
API
Acetazolamide
CAS: 59-66-5
API
Acetic Acid
CAS: 64-19-7
Excipient
Acetylcysteine
CAS: 616-91-1
API
Acetylspiramycin
CAS: 24916-51-6
API
Aciclovir
CAS: 59277-89-3
API
Acipimox
CAS: 51037-30-0
API
Acitretin
CAS: 55079-83-9
API
FAQS
Q1: What is ChP?

ChP refers to the Pharmacopoeia of the People’s Republic of China (Chinese Pharmacopoeia). ChP is China’s official collection of standards for drug development, production, sales, utilization, supervision, and control.

ChP is updated by the Chinese Pharmacopoeia Commission every five years. The latest version is the ChP 2020, of which the API & excipient standards are listed in this database.

In China, all drugs shall comply with the ChP standards to obtain marketing authorization. Therefore, it’s necessary for drug applicants to understand and meet the standards.

Q2: What do ChP API/Excipient standards include?

The API standards generally include the following items: (1) name (Chinese name, Pinyin, and English name); (2) structural formula of organic drugs; (3) molecular formula and molecular weight; (4) sources or chemical name of organic drugs; (5) content or potency; (6) formulation; (7) production; (8) description; (9) identification; (10) test; (11) assay of content or potency; (12) category; (13) strength; (14) storage; (15) preparation; (16) label; (17) impurity information, etc.

The excipient standards generally include: (1) name (Chinese name, Pinyin, and English name); (2) structural formula of organics; (3) molecular formula, molecular weight, and CAS number; (4) sources; (5) production; (6) description; (7) identification; (8) test; (9) assay of content; (10) category; (11) storage; (12) label; (13) appendices and notes, etc.

The standards sent to you are English translations.

Q3: How much does it cost to buy the documents of standards?
Standards of one API/excipient cost 130 USD.
Q4: When will I receive the documents of standards?
The documents will be sent to your email address within two workdays after successful payment.
Q5: Can I buy ChP standards of finished dosage forms?
Our database currently provides API/excipient standards. If you need to know the standards of finished drug products, please send an email to contact@chemlinked.com. We’ll offer you the customized service of translating the corresponding standards.
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Please kindly note that the English translations of the API/excipient standards will be delivered by email within two (2) business days after successful payment.