Introduction:
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Detailed introduction:
The European Pharmacopoeia (EP) is the only reference for the quality control of drugs in Europe. All manufacturers of drugs and pharmaceutical substrates must follow the quality standards of the European pharmacopoeia in the process of promotion and use in Europe. The European Pharmacopoeia is the European standard for drug quality control. Many legal documents have made the European Pharmacopoeia a statutory standard. EP standard is widely used in the production of chemical, pharmaceutical and biological products in Europe. It is an indispensable product in European chemical industry and a reference standard for the quality of European chemical industry.
It includes active substances, excipients, pharmaceutical substances or products from chemical, animal, human or plant sources, homeopathic preparations and homeopathic raw materials, antibiotics, preparations and containers, etc.
Common problems of European Pharmacopoeia (EP)
Q1: double label problem
A1: EP is going to put double label on the outer packaging bottles of all current standard products. At present, most of the products have been replaced with double label, but a small number of products have not been pasted, which is still single label. The purpose of this experiment is to label the product on the outside so that it can be easily recorded.
Q2: small batch problem
A2: due to filling and labeling, some small batches of EP standard products (such as 1.1, 1.2, 1.3, etc.) are obtained from the same batch of large packaging. Note: the previous classification number of small batches will be gradually changed from 1a, 1b, 1c... To 1.1, 1.2, 1.3... At the same time, EP official will take necessary measures to ensure that the quality and specification of standard products in different small batches of the same batch are consistent.
Q3: purity problem
A3: it can be downloaded from http:// CRS.edqm.eu The content of the product was found on the table. If the content is not a required item, then http:// CRS.edqm.eu At this time, we can not take this standard as 100% for quantitative detection. However, when the impurity standard is used for limit detection, it should be printed on the product label or http:// CRS.edqm.eu When the content of the product is not marked on the label, the content of the impurity standard is usually 100% by default.
Q4: shelf life
A4: European pharmacopoeia standard does not indicate the shelf life on the package of the product. The official will regularly check whether the product is deteriorated. Usually, under normal storage conditions, the old batch of products is still valid before the new batch of products come out.
Adenine standard is introduced in detail
Name: adenine
CAS: 73-24-5
Product No.: ccpe900716
Specification: 20mg
Origin: Europe
List of some standard products:
Abacavir sulfate standard
Acarbose impurity standard
Acemetacin standard
Acetazolamide standard
Acyclovir standard
Atracurine standard
Adapalene standard
Adenine standard
Adenosine standard
Baicalin standard
Benperidol standard
Benzarone standard
Benzbromarone standard
Bromeperidol standard
Bumetanide standard
Buserelin standard
Busulfan standard
Carbergolin standard
Captopril standard
Carbimazole standard
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