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:
- methyl (3aR,4S,6R,6aS)-4-((tert-butoxycarbonyl)amino)-3-(pentan-3- yl)-3a,5,6,6a-tetrahydro-4H-cyclopenta[d]isoxazole-6-carboxylate
- Structure:
- Chemical Name:
- 3-Pyridinecarboxamide, 5-chloro-N-[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]-1,6-dihydro-6-oxo-, hydrochloride (1:)
- CAS:
- 570403-05-3
- MF:
- C23H26Cl3N5O2S2
- Chemical Name:
- Avatrombopag Impurity 49
- Chemical Name:
- Avatrombopag Impurity 56
- Chemical Name:
- Pterosin A-2-O-glucoside
- Structure:
- Chemical Name:
- 2-(4-(2-(4-(1-(2-hydroxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropanoic acid
- MF:
- C26H33N3O3
- Chemical Name:
- Carbazochrome Sodium Sulfonate Impurity IV (Carbazochrome Sodium Sulfonate Impurity 4)
- Chemical Name:
- Telmisartan EP Impurity B Complete Set
- Chemical Name:
- Atracurium Impurity G Complete Set
- Chemical Name:
- Cetrorelix Impurity 12
- Chemical Name:
- Cetrorelix Impurity 5 (6-D-Orn)
- Chemical Name:
- Tenofovir impurity EE
- Chemical Name:
- Peramivir Intermediate Impurity 35
- Chemical Name:
- Peramivir Intermediate Impurity 40
- Chemical Name:
- Alvatrombopag Impurity 999
- Chemical Name:
- Canagliflozin impurities 16 drops
- Structure:
- Chemical Name:
- FENOFIBRIC ACID ETHYL ESTER
- CAS:
- 42019-08-9
- MF:
- C19H19ClO4
- Structure:
- Chemical Name:
- (2R,3S/2S,3R)-2-(2,4-Difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol
- CAS:
- 182230-43-9
- MF:
- C16H14F3N5O
- Chemical Name:
- Bumetanide Impurity 8
- Structure:
- Chemical Name:
- Benzenesulfonamide, N-(2-aminoethyl)-3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxy-
- CAS:
- 448184-52-9
- MF:
- C19H26N6O4S
- Chemical Name:
- Avibactam Impurity 04
- Chemical Name:
- Latamoxef Impurity C
- Structure:
- Chemical Name:
- (S)-2-(pentylsulfonamido)-3-(4-(4-(piperidin-4-yl)butoxy)phenyl)propanoic acid
- CAS:
- 1332692-49-5
- MF:
- C23H38N2O5S
- Structure:
- Chemical Name:
- O-Demethyl elagolix sodium
- CAS:
- 832720-51-1
- MF:
- C31H28F5N3O5
- Chemical Name:
- Pitavastatin Impurity 81
- Chemical Name:
- Palonosetron impurity 30XH
- Chemical Name:
- Pazopanib ImpurityABCDEFGHJKL
- Structure:
- Chemical Name:
- 1-(4-(2-Dimethylamino)-2-ethoxyphenyl butanone
- CAS:
- 68047-07-4
- MF:
- C20H25NO2
- Structure:
- Chemical Name:
- 2-(4-ethylpiperazin-1-yl)-4-(4-methoxyphenyl)-5,6,7,8,9,10-hexahydrocycloocta[b]pyridine
- MF:
- C24H33N3O
- Chemical Name:
- Rosuvastatin Impurity 163
- Chemical Name:
- Rosuvastatin Impurity 150
- Structure:
- Chemical Name:
- 1-[2-(2,4-difluorophenyl)-2,3-epoxypropyl]-1h-1,2,4-triazole
- CAS:
- 86386-76-7
- MF:
- C11H9F2N3O
- Chemical Name:
- 7-PACE Impurity 1
- Structure:
- Chemical Name:
- 1-(3-Cyanopyridyl-2)-2-Phenyl-4-Methylpyperazine
- CAS:
- 61337-88-0
- MF:
- C17H18N4
- Chemical Name:
- Ertapenem Impurity E(USP)
- Structure:
- Chemical Name:
- Pyrazinecarboxaldehyde, trimethyl- (9CI)
- CAS:
- 186534-02-1
- MF:
- C8H10N2O
- Structure:
- Chemical Name:
- Acetamide, N-[4-[(2R)-3-cyano-2-methyl-1-oxopropyl]phenyl]-
- CAS:
- 2428573-45-7
- MF:
- C13H14N2O2
- Structure:
- Chemical Name:
- 4-[6-(2-Chloroethyl)-3,6,7,8-tetrahydro-3-methylimidazo[4,5-h][1,4]benzothiazin-2-yl]butanoic acid
- CAS:
- 2469039-29-8
- MF:
- C16H21Cl2N3O2S
- Structure:
- Chemical Name:
- D-erythro-Pent-4-enose, 4,5-dideoxy-2,3-O-(1-methylethylidene)- (9CI)
- CAS:
- 155934-55-7
- MF:
- C8H12O3
- Chemical Name:
- Isavuconazole Impurity 41
- Structure:
- Chemical Name:
- Carbamic acid, N-benzoyl-N-(2-phenylethyl)-, (2R)-1-azabicyclo[2.2.2]oct-2-yl ester
- CAS:
- 1798817-91-0
- MF:
- C23H26N2O3
- Chemical Name:
- 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1,1-bis((5-methylpyridin-3-yl)methyl)piperidin-1-ium
- Chemical Name:
- Roxadustat Impurity 15
- Structure:
- Chemical Name:
- (1S,3S,7S,8S,8aR)-8-(2-((2R,4R)-4-hydroxy-6-oxotetrahydro-2H- pyran-2-yl)ethyl)-3,7-dimethyl-1,2,3,4,6,7,8,8a-octahydronaphthalen- 1-yl 2,2-dimethylbutanoate
- CAS:
- 132487-01-5
- MF:
- C25H40O5
- Chemical Name:
- 3-(hydroxy(2-methyl-1H-imidazol-1-yl)methyl)-9-(hydroxymethyl)-1,2,3,9-tetrahydro-4H-carbazol-4-one
- Chemical Name:
- Perospirone Impurity 18
- Chemical Name:
- Perospirone Impurity 3
- CAS:
- 1002359-81-0
- MF:
- C8H11NO2
- Chemical Name:
- Dolutegravir Impurity 13(Sodium Salt)
- Chemical Name:
- Paxlovid Impurity 10
- Chemical Name:
- Fondaparinux sodium impurity 4
- Chemical Name:
- Ampicillin Impurity W
- Structure:
- Chemical Name:
- 2-(5-Acetyl-2-ethoxyphenyl)-5-methyl-7-propyl-imidazo[5,1-f][1,2,4]triazin-4(1H)-one
- CAS:
- 358390-43-9
- MF:
- C19H22N4O3
- Structure:
- Chemical Name:
- Olopatadine Ethyl Ester
- CAS:
- 113806-03-4
- MF:
- C23H27NO3
- Chemical Name:
- Empagliflozin Impurity 80
- Chemical Name:
- Empagliflozin Impurity 92
- Chemical Name:
- Iohexol Impurity N
- Structure:
- Chemical Name:
- Pitavastatin 5-Oxo Impurity Calcium Salt
- CAS:
- 2180095-22-9
- MF:
- C25H24CaFNO4
- Structure:
- Chemical Name:
- 1-(2-bromo-3,5-dihydroxyphenyl)ethanone
- CAS:
- 2092614-65-6
- MF:
- C8H7BrO3
- Structure:
- Chemical Name:
- Lenvatinib impurity LFZZ-18
- MF:
- C11H8Cl2N2O2
- Structure:
- Chemical Name:
- Rosuvastatin Impurity 121
- CAS:
- 140164-51-8
- MF:
- C10H18O5
- Chemical Name:
- Brivaracetam Impurity 38
- Chemical Name:
- Isavuconazole Impurities 04
- Chemical Name:
- Ticagrelor Impurity 119
- Chemical Name:
- Ticagrelor Impurity 118
- Structure:
- Chemical Name:
- D-erythro-Hexonic acid, 2,4-dideoxy-3,5-O-(1-methylethylidene)-, acetate (9CI)
- CAS:
- 402508-35-4
- MF:
- C11H18O6
- Structure:
- Chemical Name:
- L-Alanine, 3-[(S)-(carboxymethyl)sulfinyl]-
- CAS:
- 112246-66-9
- MF:
- C5H9NO5S
- Structure:
- Chemical Name:
- 2-Propanone, 1-[4,5-dihydro-2-(4-methyl-1-piperazinyl)-4-thioxo-3H-1,5-benzodiazepin-3-ylidene]-
- CAS:
- 1902955-67-2
- MF:
- C17H20N4OS
- Structure:
- Chemical Name:
- 3(2H)-Pyridazinone, 6-[4-(ethylamino)phenyl]-4,5-dihydro-5-methyl-
- CAS:
- 52240-42-3
- MF:
- C13H17N3O
- Structure:
- Chemical Name:
- Benzoic acid, 4-[[4-(aminocarbonyl)-1-piperidinyl]methyl]-
- CAS:
- 938143-02-3
- MF:
- C14H18N2O3
- Chemical Name:
- 2,4-bis(1-(2,3-dimethylphenyl)ethyl)-1H-imidazole
- Chemical Name:
- 2-((4R,6S)-6-((2-((4R,6S)-6-(hydroxymethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetoxy)methyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetic acid
- Structure:
- Chemical Name:
- Crisaborole intermediate
- CAS:
- 1187230-70-1
- MF:
- C14H14BNO3
- Structure:
- Chemical Name:
- Glycine, (2R)-N-[(4-ethyl-2,3-dioxo-1-piperazinyl)carbonyl]-2-phenylglycyl-2-[(2S,4S)-4-carboxy-5,5-dimethyl-2-thiazolidinyl]-, (2R)-
- CAS:
- 1449784-97-7
- MF:
- C23H29N5O8S
- Structure:
- Chemical Name:
- 6-Quinolinecarboxamide, 4-[(2-chloro-4-hydroxyphenyl)amino]-7-methoxy-
- CAS:
- 2380197-89-5
- MF:
- C17H14ClN3O3
- Structure:
- Chemical Name:
- 1-Pyrrolidineacetic acid, α-ethyl-2-oxo-4-propyl-, methyl ester, (4R)-
- CAS:
- 930123-52-7
- MF:
- C12H21NO3
- Chemical Name:
- Traxipide impurity
- Structure:
- Chemical Name:
- Benzeneacetic acid, 4-[2-[4-[1-(2-ethoxyethyl)-1H-benzimidazol-2-yl]-1-piperidinyl]ethyl]-α,α-dimethyl-, methyl ester
- CAS:
- 1181267-38-8
- MF:
- C29H39N3O3
- Structure:
- Chemical Name:
- Benzenemethanol, 4-[2-(1-methylethoxy)ethoxy]-
- CAS:
- 1039828-27-7
- MF:
- C12H18O3
- Structure:
- Chemical Name:
- Brivaracetam Impurity 7 HCl
- CAS:
- 357338-46-6
- MF:
- C13H27ClN2O3
- Structure:
- Chemical Name:
- Bisacodyl Impurity 1
- CAS:
- 13004-51-8
- MF:
- C18H15NO2
- Chemical Name:
- Vecuronium Bromide ImpurityACDEFGHJKL
- Structure:
- Chemical Name:
- Butanedioic acid, 2-[[2-methyl-1-(phenylmethyl)-1H-imidazol-5-yl]methylene]-, 1-ethyl ester, (2E)-
- CAS:
- 1640981-02-7
- MF:
- C18H20N2O4
- Structure:
- Chemical Name:
- Carbamic acid, [2-hydroxy-1-methyl-2-[3-(phenylmethoxy)phenyl]ethyl]-, phenylmethyl ester, [R-(R*,S*)]- (9CI)
- CAS:
- 31301-86-7
- MF:
- C24H25NO4
- Structure:
- Chemical Name:
- 9H-Purine-9-ethanol, 6-amino-β-methyl-
- CAS:
- 20776-34-5
- MF:
- C8H11N5O
- Structure:
- Chemical Name:
- 2-amino-5-[(3,4,5-trimethoxyphenyl)methyl]-1H-pyrimidin-4-one
- CAS:
- 92440-76-1
- MF:
- C14H17N3O4
- Chemical Name:
- Edoxaban impurity ABCDEFGHJKL
- Chemical Name:
- (2R,3R)-3-amino-2-methyl-4-oxoazetidine-1-sulfonic acid
- Chemical Name:
- Osimertinib impurity01
- Structure:
- Chemical Name:
- (±)-N-[3-acetyl-4-[2-hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]acetamide monohydrochloride
- CAS:
- 73899-76-0
- MF:
- C16H25ClN2O4
- Structure:
- Chemical Name:
- Hexanoic acid, 6-chloro-3,5-dihydroxy-, (3R,5S)-
- CAS:
- 958358-67-3
- MF:
- C6H11ClO4
- Chemical Name:
- Oseltamivir Impurity 78
- Chemical Name:
- Oseltamivir Impurity 67
- Chemical Name:
- Ixazomib Impurity ABCDEFGHJKL
- Structure:
- Chemical Name:
- 2-[[[4-(2,2-dimethyl-1-oxopropoxy)phenyl]sulfonyl]amino]-Benzoic acid
- CAS:
- 188114-98-9
- MF:
- C18H19NO6S