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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- Chemical Name:
- Sugammadex sodium Org199010-1 Impurity
- Chemical Name:
- Sugammadex sodium Org226100-1 Impurity
- Chemical Name:
- Afatinib impurity 32
- Chemical Name:
- Butyphthalide impurity 26
- Chemical Name:
- Butyphthalide impurity 32
- Chemical Name:
- Canagliflozin Impurity 30
- Structure:
- Chemical Name:
- Celecoxib Impurity 20
- CAS:
- 343853-74-7
- MF:
- C6H7N3O3S
- Chemical Name:
- Emtricitabine Impurity CFTU1
- Chemical Name:
- Esomeprazole Impurity 34
- Chemical Name:
- Febuxostat Impurity 82
- Chemical Name:
- Febuxostat Impurity 87
- Chemical Name:
- Gefitinib Impurity R
- Structure:
- Chemical Name:
- Imatinib impurity 31
- CAS:
- 1356565-47-3
- MF:
- C17H17N7
- Chemical Name:
- LCZ696(valsartan + sacubitril) impurity 33
- Chemical Name:
- Lenvatinib Impurity 26
- Chemical Name:
- Ozagrel impurity C
- Chemical Name:
- Regorafenib Impurity 24
- Chemical Name:
- Regorafenib Impurity 32
- Chemical Name:
- Sitafloxacin Impurity ZZ-A-01
- Structure:
- Chemical Name:
- Solifenacin impurity 18
- CAS:
- 1243274-83-0
- MF:
- C14H17NO3
- Chemical Name:
- Tofacitinib Impurity 87
- Chemical Name:
- Tofacitinib Impurity 92
- Structure:
- Chemical Name:
- Amlodipine EP Impurity K
- MF:
- C26H31ClN2O8S
- Chemical Name:
- Febuxostat Impurity 49
- Structure:
- Chemical Name:
- Budesonide Impurity 6
- CAS:
- 131918-73-5
- MF:
- C21H26O6
- Structure:
- Chemical Name:
- Timolol Impurity 1
- CAS:
- 75014-25-4
- MF:
- C13H24N4O5S
- Structure:
- Chemical Name:
- Telmisartan EP-J
- CAS:
- 885045-90-9
- MF:
- C33H29ClN4O2
- Structure:
- Chemical Name:
- Pitavastatin Impurity 29
- CAS:
- 148516-15-8
- MF:
- C25H20FNO2
- Structure:
- Chemical Name:
- Rosuvastatin Related Compound 6
- CAS:
- 521973-99-9
- MF:
- C13H23ClO4
- Structure:
- Chemical Name:
- Medetomidine impurity
- CAS:
- 2250243-44-6
- MF:
- C20H22N2O
- Chemical Name:
- Linagliptin Impurity 51
- Chemical Name:
- Carfilzomib Impurity YGF
- Structure:
- Chemical Name:
- Pitavastatin Impurity 45
- CAS:
- 1258947-29-3
- MF:
- C29H32FNO4
- Chemical Name:
- Irinotecan Impurity L
- Chemical Name:
- Irinotecan Impurity H
- Chemical Name:
- LCZ696（valsartan + sacubitril） impurity 27
- Chemical Name:
- Caspofungin Impurity EJT2
- Chemical Name:
- Tofacitinib Impurity 100
- Chemical Name:
- Afatinib impurity 37
- Chemical Name:
- Vildagliptin Impurity 36
- Chemical Name:
- Butyphthalide impurity 52
- Structure:
- Chemical Name:
- Tofacitinib Impurity 102
- CAS:
- 1615709-90-4
- MF:
- C14H17ClN2
- Structure:
- Chemical Name:
- Pralatrexate Impurity 12
- CAS:
- 1451250-74-0
- MF:
- C23H23N7O5
- Chemical Name:
- Pralatrexate Impurity 17
- Chemical Name:
- Pitavastatin Impurity 49
- Chemical Name:
- Pitavastatin Impurity 55
- Chemical Name:
- Lenvatinib Impurity 40
- Chemical Name:
- Tazobactam Impurity 11
- Chemical Name:
- Crisaborole Impurity 2
- Chemical Name:
- Canagliflozin Impurity 58
- Chemical Name:
- Canagliflozin Impurity 63
- Chemical Name:
- Levetiracetam Impurity 23
- Chemical Name:
- Selexipag Impurity 4
- CAS:
- 2928611-77-0
- Structure:
- Chemical Name:
- Levosimendan Impurity 10
- CAS:
- 134678-47-0
- MF:
- C11H12N2O2
- Chemical Name:
- Cabozantinib impurity I
- Chemical Name:
- Rotigotine Impurity 2
- Chemical Name:
- Rotigotine Impurity 9
- Chemical Name:
- Olprinone Impurity 5
- Structure:
- Chemical Name:
- Vitamin B5 Impurity 1
- CAS:
- 897045-90-8
- MF:
- C12H22N2O6
- Chemical Name:
- Cilastatin Impurity 5
- Structure:
- Chemical Name:
- (R)-3-(4-(2-chloro-5-iodobenzyl)phenoxy)tetrahydrofuran
- CAS:
- 2194590-02-6
- MF:
- C17H16ClIO2
- Structure:
- Chemical Name:
- Sitagliptin Impurity 69
- CAS:
- 2172430-88-3
- MF:
- C15H16F3NO4
- Structure:
- Chemical Name:
- Dimethyl (1-Diazo-2-oxopropyl)phosphonate
- CAS:
- 90965-06-3
- MF:
- C5H9N2O4P
- Chemical Name:
- Trimetazidine Impurity 8
- Chemical Name:
- MeropeneM iMpurity 5
- Structure:
- Chemical Name:
- Perindopril IMpurity 6
- CAS:
- 2163775-15-1
- MF:
- C8H15NO4
- Structure:
- Chemical Name:
- Oseltamivir Impurity 48
- CAS:
- 651324-04-8
- MF:
- C18H33NO4
- Structure:
- Chemical Name:
- Tamsulosin impurity 5
- MF:
- C20H28N2O5S
- Chemical Name:
- Flucloxacillin Impurity 5
- Chemical Name:
- Nitrendipine iMpurity G
- Structure:
- Chemical Name:
- (S)-N-(5-((S)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide
- CAS:
- 2409589-59-7
- MF:
- C21H22F2N6O2
- Chemical Name:
- Afatinib Impurity 53
- Chemical Name:
- Afatinib Impurity 68
- Chemical Name:
- Alogliptin Impurity 26
- Chemical Name:
- Empagliflozin Impurity 61
- Chemical Name:
- Ipragliflozin Impurity 3
- CAS:
- 1922933-61-6
- Chemical Name:
- Isavuconazole Impurity 30
- Chemical Name:
- Levetiracetam Impurity 27
- Chemical Name:
- Linagliptin Impurity 58
- Chemical Name:
- Oseltamivir Impurity 33
- Chemical Name:
- Oseltamivir Impurity 49
- Chemical Name:
- Palbociclib Impurity 52
- Chemical Name:
- Palbociclib Impurity 37
- Structure:
- Chemical Name:
- Pazufloxacin Impurity 16
- CAS:
- 165071-10-3
- MF:
- C14H10FNO6
- Chemical Name:
- Pimecrolimus Impurity 4
- Chemical Name:
- Posaconazole Impurity 73
- Structure:
- Chemical Name:
- Rosuvastatin Impurity 90
- CAS:
- 2226413-62-1
- MF:
- C38H44F2N6O8S2
- Chemical Name:
- Tofacitinib Impurity 110
- Chemical Name:
- Tofacitinib Impurity 115
- Chemical Name:
- Trelagliptin Impurity 27
- Structure:
- Chemical Name:
- Vildagliptin Impurity 30
- CAS:
- 918830-94-1
- MF:
- C10H17NO2
- Structure:
- Chemical Name:
- N-methyl-N-((3R,4R)-4-methylpiperidin-3-yl)-7H-pyrrolo[2,3-d] pyrimidin-2-amine
- MF:
- C13H19N5
- Structure:
- Chemical Name:
- Tolvaptan Impurity 6
- CAS:
- 1432725-24-0
- MF:
- C18H19ClN2O2
- Chemical Name:
- Esmolol impurity B
- Chemical Name:
- Esmolol impurity F
- Chemical Name:
- Diquafosol Impurity E
- Chemical Name:
- Bortezomib Impurity 39
- Chemical Name:
- Agomelatine Impurity 1
- Chemical Name:
- Sunitinib Impurity 5
- Chemical Name:
- Silodosin Impurity 6