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:
- Cefathiamidine Impurity 7
- Structure:
- Chemical Name:
- Empagliflozin Impurity 62
- CAS:
- 1620758-30-6
- MF:
- C23H27ClO8
- Chemical Name:
- Emtricitabine Impurity 5
- Chemical Name:
- Esomeprazole Impurity 42
- Chemical Name:
- Gadobutrol Impurity 7
- Structure:
- Chemical Name:
- Imatinib Impurity 27
- CAS:
- 67013-55-2
- MF:
- C8H5Br2N
- Chemical Name:
- Isavuconazole Impurity 31
- Chemical Name:
- Linagliptin Impurity 59
- Chemical Name:
- Oseltamivir Impurity 56
- Chemical Name:
- Palbociclib Impurity 38
- Chemical Name:
- Pemetrexed Impurity 38
- Chemical Name:
- Posaconazole Impurity 74
- Chemical Name:
- Rabeprazole Impurity 21
- Chemical Name:
- Sitagliptin Impurity 52
- Chemical Name:
- Tafluprost Impurity 5
- Chemical Name:
- Ticagrelor Impurity 112
- Structure:
- Chemical Name:
- Ticagrelor Impurity 96
- CAS:
- 1643413-84-6
- MF:
- C9H9F2N
- Chemical Name:
- Tofacitinib Impurity 116
- Chemical Name:
- Tofacitinib Impurity 121
- Chemical Name:
- Trelagliptin Impurity 28
- Structure:
- Chemical Name:
- Vildagliptin Impurity 31
- CAS:
- 119694-48-3
- MF:
- C10H14N4O6
- Chemical Name:
- Beclometasone Impurity M
- Structure:
- Chemical Name:
- O-DESMETHYLCARVEDILOL
- CAS:
- 72956-44-6
- MF:
- C23H24N2O4
- Structure:
- Chemical Name:
- Tolvaptan Impurity 7
- CAS:
- 1432725-23-9
- MF:
- C26H26N2O3
- Chemical Name:
- Dexchlorpheniramine impurity E
- Chemical Name:
- Diquafosol Impurity F
- Chemical Name:
- Dasatinib iMpurity F
- Chemical Name:
- Palbociclib Impurity 2
- Chemical Name:
- Axitinib Impurity 6
- Structure:
- Chemical Name:
- Levofloxacin Impurity 16
- MF:
- C18H20FN3O4
- Structure:
- Chemical Name:
- Venlafaxine Impurity 13
- CAS:
- 727728-51-0
- MF:
- C17H27NO2
- Chemical Name:
- Erlotinib Impurity 20
- Chemical Name:
- Febuxostat Impurity 42
- Structure:
- Chemical Name:
- Pregabalin Impurity 11
- CAS:
- 2375259-86-0
- MF:
- C8H16ClNO2
- Chemical Name:
- Ticagrelor Impurity 44
- Chemical Name:
- Exemestane Impurity 2
- Chemical Name:
- Empagliflozin Impurity 4
- Chemical Name:
- Moxifloxacin Impurity 14
- Chemical Name:
- 2-Benzothiazolamine
- Chemical Name:
- Cefodizime Impurity E
- Chemical Name:
- Penicillin Impurity C
- Chemical Name:
- Cefminox Sodium impurity C
- Chemical Name:
- Cefotiam Impurity C
- Structure:
- Chemical Name:
- Dequalinium EP Impurity B
- CAS:
- 747387-02-6
- MF:
- C30H40N4+2
- Chemical Name:
- Peramivir Impurity F
- Structure:
- Chemical Name:
- 1-{[4-BENZYL-2-(3,4-DIMETHOXYPHENYL)-4H-CHROMEN-3-YL]METHYL}PIPERIDINIUM CHLORIDE
- MF:
- C30H34ClNO3
- Structure:
- Chemical Name:
- 4-Hydroxyisophthalonitrile
- CAS:
- 34133-58-9
- MF:
- C8H4N2O
- Structure:
- Chemical Name:
- 4-Thia-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid, 6-(1-hydroxyethyl)-7-oxo-3-(tetrahydro-2-furanyl)-, [5R-[3(S*),5α,6α(R*)]]- (9CI)
- CAS:
- 106560-13-8
- MF:
- C12H15NO5S
- Structure:
- Chemical Name:
- 1-Naphthalenecarboxylic acid, 8-[[(3S)-1-azabicyclo[2.2.2]oct-3-ylamino]methyl]-5,6,7,8-tetrahydro-, (8S)-
- CAS:
- 2407763-21-5
- MF:
- C19H26N2O2
- Chemical Name:
- Peramivir Impurity 58
- Structure:
- Chemical Name:
- 1-Naphthalenamine, 4-(2,3-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-, (1R,4R)-rel-
- CAS:
- 2124277-87-6
- MF:
- C17H17Cl2N
- Chemical Name:
- Voriconazole toxic impurity 2
- Chemical Name:
- Avatrombopag Impurity 31
- Structure:
- Chemical Name:
- Cisatracurium besylate impurity19
- CAS:
- 96946-52-0
- MF:
- C59H77N2O15S+
- Chemical Name:
- Empagliflozin Impurity 81
- Chemical Name:
- Iohexol Impurity M
- Chemical Name:
- Relugolix Impurity 18
- Chemical Name:
- Rabeprazole Impurity 15
- Structure:
- Chemical Name:
- 4-((2-amino-2-oxoethyl)(hydroxy)amino)butanoic acid
- CAS:
- 2454698-45-2
- MF:
- C6H12N2O4
- Structure:
- Chemical Name:
- Lenvatinib Impurity LFZZ-8
- MF:
- C44H40Cl2N8O8
- Chemical Name:
- Pemetrexed disodium Impurity 19
- Chemical Name:
- Brivaracetam Impurity 32
- Structure:
- Chemical Name:
- Apixaban Impurity 56
- CAS:
- 2444918-46-9
- MF:
- C15H19N3O2
- Chemical Name:
- Ticagrelor Impurity 107
- Structure:
- Chemical Name:
- 2-Thiazolamine, 5-bromo-4-(5-bromo-4-chloro-2-thienyl)-
- CAS:
- 2401867-89-6
- MF:
- C7H3Br2ClN2S2
- Structure:
- Chemical Name:
- Carbamic acid, N-[1,1'-biphenyl]-2-yl-, 1-[2-[[4-(hydroxymethyl)benzoyl]methylamino]ethyl]-4-piperidinyl ester
- CAS:
- 1682660-39-4
- MF:
- C29H33N3O4
- Structure:
- Chemical Name:
- Atomoxetine Impurity 15
- CAS:
- 881995-45-5
- MF:
- C19H23NO2
- Structure:
- Chemical Name:
- Pitavastatin Impurity 13 (Pitavastatin 2,4,6-Triene Impurity)
- CAS:
- 2086271-67-0
- MF:
- C25H20FNO2
- Chemical Name:
- (2S,5R)-5-(4-amino-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2- carboxylic acid sodium
- Chemical Name:
- impurity 39
- Chemical Name:
- (2R,3R,4R,5S)-6-((2,4-dibromo-6-((cyclohexyl(methyl)amino)methyl)phenyl)amino)hexane-1,2,3,4,5-pentaol
- Chemical Name:
- Bosutinib Impurity 32
- Structure:
- Chemical Name:
- 6,6'-Methylenebis[1,2,3,9-tetrahydro-9-methyl-3-methylene-4H-carbazol-4-one
- CAS:
- 1365727-09-8
- MF:
- C29H26N2O2
- Structure:
- Chemical Name:
- Ampicillin Dimer Disodium Salt
- CAS:
- 94730-51-5
- MF:
- C32H39N6NaO8S2
- Structure:
- Chemical Name:
- Oseltamivir Impurity
- CAS:
- 221386-94-3
- MF:
- C11H17N3O5
- Chemical Name:
- Bumetanide Impurity 3
- Chemical Name:
- Cefoxitin EP Impurity F (S-methoxy cefoxitin)
- Structure:
- Chemical Name:
- alpha-[4-[2-(dimethylamino)ethoxy]phenyl]-beta-ethyl-alpha-phenylphenethyl alcohol
- CAS:
- 748-97-0
- MF:
- C26H31NO2
- Chemical Name:
- Brivaracetam Impurity 53
- Structure:
- Chemical Name:
- ethyl hydrogen [R-(R*,R*)]-tartrate
- CAS:
- 608-89-9
- MF:
- C6H10O6
- Structure:
- Chemical Name:
- ethyl 2,2,4-trichloro-3-oxobutyrate
- CAS:
- 85153-67-9
- MF:
- C6H7Cl3O3
- Chemical Name:
- Neodigoxin
- CAS:
- 55576-67-5
- MF:
- C41H64O14
- Chemical Name:
- (S)-6-((R)-2-amino-2-phenylacetamido)-2,2-dimethyl-7-oxo-2,3,4,7-tetrahydro-1,4-thiazepine-3-carboxylic acid
- Structure:
- Chemical Name:
- (R,R)-Palonosetron N-Oxide
- MF:
- C19H24N2O2
- Structure:
- Chemical Name:
- [R(R*,R*]-2-amino-1-[p-(methylsulphonyl)phenyl]propane-1,3-diol
- CAS:
- 51458-28-7
- MF:
- C10H15NO4S
- Structure:
- Chemical Name:
- 16alpha,17,21-trihydroxypregna-1,4,9(11)-triene-3,20-dione 21-acetate
- CAS:
- 77017-20-0
- MF:
- C23H28O6
- Structure:
- Chemical Name:
- Pyrimidine, 4-chloro-5-nitro-2-(propylthio)-
- CAS:
- 2518331-26-3
- MF:
- C7H8ClN3O2S
- Chemical Name:
- Oseltamivir Impurity 110
- Chemical Name:
- Oseltamivir Impurity 108
- Chemical Name:
- Oseltamivir Impurity 102
- Structure:
- Chemical Name:
- 1H-Pyrazole-1-propanenitrile, 4-(6-amino-5-formyl-4-pyrimidinyl)-β-cyclopentyl-, (βR)-
- CAS:
- 2606144-45-8
- MF:
- C16H18N6O
- Structure:
- Chemical Name:
- 4-Piperidinecarboxylic acid, 1-(4-pyridinylcarbonyl)-, ethyl ester
- CAS:
- 252263-38-0
- MF:
- C14H18N2O3
- Chemical Name:
- (S)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-1H-pyrrol-1-yl) ethyl)-5,6-dihydro-2H-pyran-2-one
- Structure:
- Chemical Name:
- 1,4-bis(4-nitrophenyl)piperazine
- CAS:
- 16264-05-4
- MF:
- C16H16N4O4
- Structure:
- Chemical Name:
- di(2,4-xylyl) disulphide
- CAS:
- 13616-83-6
- MF:
- C16H18S2