Standard
In the analysis work, it often demanded to apply high-quality compound with the exact content being accurate in order to be compared as the detection control or used to calibrate the instrument, the compound is known as standard sample.
Standard refers to the standard substance used for measuring the potency of biological products. When the production department submits to a higher authority for approval of the quality standard of the biological product, they should also provide the standard sample (indicated in unit (μ)) used for measuring the potency of the tested product.
According to different application, the verification products can be divided into biological standard for the testing of biological products, endocrine drugs, antibiotics and other bioassay and chemical standards including:
1 chemical standards used for calibration of the instrument;
2 chemical reference standards used for calibration of the ultraviolet or infrared spectrum of the drugs;
3 control standards used for the purity test of drugs as well as the impurity control or as the control standards for content determination of the medicine.
In the page 67 of the appendix in the People's Republic of China Pharmacopoeia 1990 1st edition, we can find hundreds kinds of standards including bornyl ester acetate, eugenol and panaxadiol as well as 39 kinds of control medicine for the purify inspection of traditional Chinese medicine, impurity control or the content determination.
International standards
This refers to standard sample, with the potency units of the existing international standard sample potency units as baseline, undergoing further calibration of its potency units on the basis of a wide range of international cooperation. Its potency is expressed in 1U. For a certain product, for the establishment of the first international standard sample, the determination of its potency units should be consulted and decided by the Committee of Experts before the announcement. The international standard is a standard reference substance for worldwide preparation of national standards, so that the international standards can achieve unity.
Reagents and standards
All reagents in the food analysis laboratories should be clearly labeled to indicate the following: 1 name; 2 the date of preparation; 3 Signature from the people in charge; 4 if necessary, we need to add content such as safety and validity and so on.
Most food analysis should use standard sample as reference for qualitative and quantitative determination. The standard sample should be classified according to the following classification methods: 1 international standard; 2 national standards; 3 internal standard; 4 other standards.
Receptacle for reference standards should be clearly affixed to the label, to indicate the following: 1 name; 2 standard document number; 3 Opening times; 4 Validity; 5 Signature.
In addition, the laboratory should keep all the necessary specific files for all the necessary reference standards.
Capacity analysis standard solution should also be strictly managed. It should be clearly posted on all the standard solution containers with labels to indicate: 1 name; 2 concentration; 3 formulation date; 4 No of formulated procedures; 5 storage conditions; 6 validity; 7 Signature from people in charge.
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- Structure:
- Chemical Name:
- Rivaroxaban Impurity 14
- CAS:
- 1429334-02-0
- MF:
- C15H21N3O4
- Chemical Name:
- Ticagrelor Impurity 69
- Chemical Name:
- Tofacitinib Impurity 71
- Chemical Name:
- Tofacitinib Impurity 79
- Structure:
- Chemical Name:
- Topiroxostat Impurity 5
- CAS:
- 2050015-91-1
- MF:
- C7H6N4O
- Structure:
- Chemical Name:
- Canagliflozin-10
- CAS:
- 2161394-94-9
- MF:
- C24H25FO5S
- Structure:
- Chemical Name:
- 2-amino-N-(2-methylphenyl)-5-thiazolecarboxamide
- CAS:
- 1184914-03-1
- MF:
- C11H11N3OS
- Structure:
- Chemical Name:
- Afatinib Impurity 23
- CAS:
- 1314777-66-6
- MF:
- C8H4FN3O3
- Structure:
- Chemical Name:
- Atracurium Impurity 25
- CAS:
- 86682-55-5
- MF:
- C20H25NO5
- Chemical Name:
- Aztreonam Impurity 7
- Chemical Name:
- Canagliflozin Impurity 43
- Structure:
- Chemical Name:
- Carvedilol Impurity 2
- CAS:
- 1198090-71-9
- MF:
- C18H17NO3
- Chemical Name:
- Clotrimazole Impurity 2
- Chemical Name:
- Dapagliflozin Impurity 33
- Chemical Name:
- Erlotinib Impurity 56
- Structure:
- Chemical Name:
- Moxifloxacin Impurity 8
- CAS:
- 1829588-19-3
- MF:
- C21H25N3O5
- Structure:
- Chemical Name:
- Olaparib Impurity 30
- CAS:
- 1460272-52-9
- MF:
- C24H21FN4O4
- Chemical Name:
- Pitavastatin Impurity 27
- Chemical Name:
- Pramipexole Impurity 24
- Chemical Name:
- Rocuronium Bromide Impurity 22
- Structure:
- Chemical Name:
- Tolterodine Impurity 1
- CAS:
- 88407-28-7
- MF:
- C22H31NO
- Structure:
- Chemical Name:
- Voriconazole Impurity 7
- CAS:
- 239807-04-6
- MF:
- C16H14F3N5O
- Chemical Name:
- Apremilast Impurity SJM
- Chemical Name:
- Aprepitant Impurity 28
- Chemical Name:
- AZD9291 Osimertinib Impurity 3
- Chemical Name:
- Dextrorotation lansoprazole Impurity K
- Chemical Name:
- Doxofylline Impurity A
- Chemical Name:
- lansoprazole Impurity 24
- Chemical Name:
- lansoprazole Impurity 30
- Chemical Name:
- meta-dyhydroxy Sugammadex sodium Impurity 2
- Chemical Name:
- Palbociclib Impurity 29
- Chemical Name:
- Palbociclib Impurity 34
- Chemical Name:
- Ropivacaine Impurity 38
- Chemical Name:
- Ropivacaine Impurity 43
- CAS:
- 2726971-51-1
- Chemical Name:
- Sugammadex sodium Decomposition process Impurity 1
- Chemical Name:
- Sugammadex sodium Org198786-1 Impurity
- Chemical Name:
- Sugammadex sodium starting material Impurity 1
- Structure:
- Chemical Name:
- Fludarabine EP impurity H
- CAS:
- 548774-57-8
- MF:
- C10H10FN5O3
- Chemical Name:
- Afatinib impurity 31
- Chemical Name:
- Butyphthalide impurity 30
- Chemical Name:
- Cabozantinib impurity S
- Chemical Name:
- Canagliflozin Isomer Impurity 1
- Structure:
- Chemical Name:
- Celecoxib Impurity 19
- MF:
- C17H14F3N3O2S
- Chemical Name:
- Febuxostat Impurity 81
- Chemical Name:
- Gefitinib Impurity Q
- Structure:
- Chemical Name:
- Irinotecan Impurity 20 HCl
- CAS:
- 870527-52-9
- MF:
- C20H20N2O4
- Chemical Name:
- LCZ696(valsartan + sacubitril) impurity 32
- Chemical Name:
- Lenvatinib Impurity 25
- Chemical Name:
- Leosimendan azide Impurity
- Chemical Name:
- Regorafenib Impurity 23
- Chemical Name:
- Regorafenib Impurity 31
- Chemical Name:
- Sitafloxacin Impurity XT-D-01
- Chemical Name:
- Sitafloxacin Impurity ZZ-E-01
- Chemical Name:
- Tofacitinib Impurity 86
- Chemical Name:
- Tofacitinib Impurity 91
- Chemical Name:
- Gefitinib impurity N
- Structure:
- Chemical Name:
- Docetaxel Impurity 24
- CAS:
- 1217248-58-2
- MF:
- C29H34O9
- Structure:
- Chemical Name:
- Olopatadine Impurity 2
- CAS:
- 56427-76-0
- MF:
- C19H18O4
- Structure:
- Chemical Name:
- Pitavastatin Impurity 24 Sodium Salt
- CAS:
- 1980814-90-1
- MF:
- C25H24FNO6
- Structure:
- Chemical Name:
- (3S,5S)-tert-butyl 7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate
- CAS:
- 1428118-12-0
- MF:
- C37H43FN2O5
- Chemical Name:
- Ibubinib impurity
- Structure:
- Chemical Name:
- Amoxicillin EP Impurity K
- MF:
- C16H19N3O5S
- Structure:
- Chemical Name:
- Amoxicillin EP Impurity C
- CAS:
- 2088961-37-7
- MF:
- C16H19N3O5S
- Structure:
- Chemical Name:
- Amoxicillin EP Impurity C
- CAS:
- 2088961-37-7
- MF:
- C16H19N3O5S
- Structure:
- Chemical Name:
- Amoxicillin EP Impurity C
- CAS:
- 2088961-37-7
- MF:
- C16H19N3O5S
- Structure:
- Chemical Name:
- Oseltamivir Impurity
- CAS:
- 212504-89-7
- MF:
- C14H26N2O3
- Chemical Name:
- Tofacitinib Impurity QTD
- Chemical Name:
- LCZ696（valsartan + sacubitril） impurity 26
- Chemical Name:
- Cabozantinib impurity 31
- Structure:
- Chemical Name:
- Carvedilol Impurity COH
- CAS:
- 51997-50-3
- MF:
- C15H13NO2
- Structure:
- Chemical Name:
- Pregabalin Impurity 10
- CAS:
- 69680-50-8
- MF:
- C7H11NO3
- Chemical Name:
- Butyphthalide impurity 51
- Chemical Name:
- Canagliflozin Impurity 41
- Chemical Name:
- Pitavastatin Impurity 36
- Chemical Name:
- Pralatrexate Impurity 11
- Chemical Name:
- Pralatrexate Impurity 16
- Chemical Name:
- Pitavastatin Impurity 48
- Chemical Name:
- Pitavastatin Impurity 53
- Chemical Name:
- Lenvatinib Impurity 39
- CAS:
- 2664101-53-3
- Chemical Name:
- Tazobactam Impurity 10
- Chemical Name:
- Crisaborole Impurity 1
- Chemical Name:
- Canagliflozin Impurity 57
- Chemical Name:
- Canagliflozin Impurity 62
- Chemical Name:
- Apixaban Degradation of Impurity
- Chemical Name:
- Levetiracetam Impurity 22
- Structure:
- Chemical Name:
- Nifekalant Impurity 8
- Chemical Name:
- Levosimendan Impurity 9
- Chemical Name:
- Cabozantinib impurity J
- Chemical Name:
- Mixture of Pemetrexed disodium EP Impurity B and C
- Chemical Name:
- Rotigotine Impurity 3
- Structure:
- Chemical Name:
- Crisaborole Impurity 5
- CAS:
- 2141947-89-7
- MF:
- C20H20BNO4
- Chemical Name:
- Crisaborole Impurity 10
- Structure:
- Chemical Name:
- 1-(3-amino-4-(benzyloxy)phenyl)-2-((1-(4-methoxyphenyl)propan-2-yl)amino)ethan-1-ol
- CAS:
- 345288-56-4
- MF:
- C25H30N2O3
- Chemical Name:
- Olprinone Impurity 4
- Structure:
- Chemical Name:
- Ribavirin Impurity 55
- CAS:
- 119240-35-6
- MF:
- C11H16O8
- Chemical Name:
- Cilastatin Impurity 4
- Structure:
- Chemical Name:
- Dyclonine Impurity 3
- CAS:
- 14146-86-2
- MF:
- C24H28O4
- Chemical Name:
- Brivaracetam Impurity F
- Chemical Name:
- MeropeneM iMpurity 4
- Chemical Name:
- Perindopril IMpurity 4