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:
- 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:
- 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+
- 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
- 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:
- 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:
- 1,2-Benzenediol, 4-(1-hydroxyethyl)-
- CAS:
- 37491-94-4
- MF:
- C8H10O3
- Structure:
- Chemical Name:
- Acetamide, 2-(diethylamino)-N-(3,4-dimethylphenyl)-
- CAS:
- 3213-16-9
- MF:
- C14H22N2O
- Chemical Name:
- Org246653-1(RRT0.31)
- Chemical Name:
- Linagliptin impurity
- Structure:
- Chemical Name:
- CEFMETAZOLE IMPURITY
- CAS:
- 76952-82-4
- MF:
- C13H16N6O5S3
- Chemical Name:
- Acyclovir impurity R
- Structure:
- Chemical Name:
- Ornidazole Impurity 7
- CAS:
- 109620-80-6
- MF:
- C6H8ClN3O3
- Chemical Name:
- (1R,2S,5aS,6aS,7aR,8aS,10aS)
- Chemical Name:
- (E)-8-(3,4-dihydroxystyryl)
- Chemical Name:
- N,N'-((2Z,2'Z)-disulfanediylbis
- Structure:
- Chemical Name:
- Cabozantinib impurity 1DYH
- CAS:
- 1621681-63-7
- MF:
- C28H24FN3O6
- Structure:
- Chemical Name:
- 1-((2R,3R)-3-(2,3-dihydrobenzo[b]
- CAS:
- 2137145-62-9
- MF:
- C23H36N2O5
- Structure:
- Chemical Name:
- Tiotropium Bromide Impurity 1
- CAS:
- 2109037-83-2
- MF:
- C18H20ClNO4S2
- Chemical Name:
- Dofetilide Impurity A
- Chemical Name:
- Sugammadex disulfide Impurity
- Structure:
- Chemical Name:
- Hispidulin 4'-O-β-D-glucopyranoside
- CAS:
- 244285-12-9
- MF:
- C22H22O11
- Chemical Name:
- Dexmedetomidine Impurity 19
- Structure:
- Chemical Name:
- Voriconazole Impurity 18
- CAS:
- 321588-94-7
- MF:
- C22H18ClF4N7O
- Structure:
- Chemical Name:
- Remdesivir impurity
- CAS:
- 1911578-74-9
- MF:
- C12H14N5O7P
- Structure:
- Chemical Name:
- ethyl 2-((4R,6R)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4- (phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-2,2-dimethyl-1,3-dioxan- 4-yl)acetate
- CAS:
- 616201-27-5
- MF:
- C38H43FN2O5
- Chemical Name:
- Peramivir Impurity 16
- Structure:
- Chemical Name:
- Tiotropium bromide Impurity 13
- CAS:
- 1459721-06-2
- MF:
- C18H19NO4S2
- Chemical Name:
- Anastrozole Impurity I
- Chemical Name:
- Fluconazole impurity I（For Chinese Pharmacopiea）
- Structure:
- Chemical Name:
- Rocuronium bromide diepoxide impurity
- MF:
- C21H30O4
- Structure:
- Chemical Name:
- 6-Methoxykaempferol 3-O-glucoside
- CAS:
- 63422-27-5
- MF:
- C22H22O12
- Chemical Name:
- Topiroxostat Impurity 39
- Chemical Name:
- Vonoprazan Impurity 60
- 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:
- INDEX NAME NOT YET ASSIGNED
- CAS:
- 2514949-81-4
- MF:
- C20H28N4O2
- 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
- Structure:
- Chemical Name:
- 3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-2-yl)amino)piperidin-1-yl)-3-oxopropanenitrile
- CAS:
- 2374700-40-8
- MF:
- C16H20N6O
- Structure:
- Chemical Name:
- 7H-Pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid, 9-fluoro-2,3-dihydro-2-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-, (S)- (9CI)
- CAS:
- 129815-82-3
- MF:
- C18H20FN3O4
- Structure:
- Chemical Name:
- Piperazine, 1-[2-[(4-methoxyphenyl)methyl]-4-methylphenyl]-
- CAS:
- 769083-63-8
- MF:
- C19H24N2O
- Structure:
- Chemical Name:
- 1,3-diisopropylurea
- CAS:
- 4128-37-4
- MF:
- C7H16N2O
- Structure:
- Chemical Name:
- Benzoic acid, 4-[7-[6-cyano-5-(trifluoromethyl)-3-pyridinyl]-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-, methyl ester
- CAS:
- 1950587-19-5
- MF:
- C21H14F4N4O3S
- Structure:
- Chemical Name:
- Benzoic acid, 4-[7-[6-cyano-5-(trifluoromethyl)-3-pyridinyl]-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-, methyl ester
- CAS:
- 1950587-19-5
- MF:
- C21H14F4N4O3S
- Structure:
- Chemical Name:
- Acetic acid, 2-[(5-bromo-2-pyridinyl)amino]-2-oxo-, ethyl ester
- CAS:
- 141354-54-3
- MF:
- C9H9BrN2O3