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:
- Tenofovir Impurity 103
- Chemical Name:
- Cabozantinib impurity 44
- Chemical Name:
- Cabozantinib impurity 40
- Chemical Name:
- Cabozantinib impurity 74
- Chemical Name:
- 5-hydroxy-N,1,2-trimethyl-1H-indole-3-carboxamide
- Chemical Name:
- Doxofylline Impurity 25
- Chemical Name:
- Dapoxetine impurity 62
- Chemical Name:
- Dapoxetine impurity 56
- Structure:
- Chemical Name:
- D(-)-AMETHOPTERIN
- CAS:
- 51865-79-3
- MF:
- C20H22N8O5
- Chemical Name:
- Bimatoprost Impurity 11
- Chemical Name:
- Bimatoprost Impurity 9
- Chemical Name:
- Dolutegravir Impurity 18
- Structure:
- Chemical Name:
- 3-(6'-oxo-1'-phenyl-1',6'-dihydro-[2,3'-bipyridin]-5'-yl)benzonitrile
- CAS:
- 380918-53-6
- MF:
- C23H15N3O
- Chemical Name:
- Lenvatinib Impurity 33
- Structure:
- Chemical Name:
- isopropyl 2-(2-oxopyrrolidin-1-yl)acetate
- CAS:
- 1249080-59-8
- MF:
- C9H15NO3
- Chemical Name:
- Pitavastatin Impurity 71
- Chemical Name:
- Rosuvastatin EP Impurity M Sodium Salt
- Chemical Name:
- Furosemide impurity 8
- Structure:
- Chemical Name:
- 9-(1,3-diacetate-2-propoxymethyl)guanine
- CAS:
- 86357-19-9
- MF:
- C13H17N5O6
- Structure:
- Chemical Name:
- Cefadroxil Impurity 6
- CAS:
- 2378158-45-1
- MF:
- C32H32N6O9S2
- Structure:
- Chemical Name:
- Loratadine Impurity 9
- CAS:
- 125743-81-9
- MF:
- C22H23ClN2O2
- Chemical Name:
- Metronidazole Impurity 1
- Structure:
- Chemical Name:
- Parecoxib Impurity 16
- CAS:
- 2235371-89-6
- MF:
- C19H18N2O4S
- Chemical Name:
- Rosuvastatin Impurity 54
- Chemical Name:
- Febuxostat Impurity 108
- Chemical Name:
- Flucloxacillin EP Impurity J
- Structure:
- Chemical Name:
- Phosphonic acid, P-[[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl]-, mono[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethyl] ester
- CAS:
- 1878175-77-9
- MF:
- C17H23N10O4P
- Structure:
- Chemical Name:
- Acetic acid, 2-[[(1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]amino]-2-oxo-, ethyl ester
- CAS:
- 480450-85-9
- MF:
- C21H31N5O5S
- Structure:
- Chemical Name:
- 3H-Oxireno[3,4]pyrrolo[2,1-b][1,3]oxazine-3-butanoic acid, 1b-(4-fluorophenyl)hexahydro-β,7-dihydroxy-7-(1-methylethyl)-1a-phenyl-7a-[(phenylamino)carbonyl]-, (βR,3R)-
- CAS:
- 1193817-52-5
- MF:
- C33H35FN2O7
- Structure:
- Chemical Name:
- Hexanoic acid, 3-formyl-, ethyl ester
- CAS:
- 54374-02-6
- MF:
- C9H16O3
- Structure:
- Chemical Name:
- D-erythro-Hexonic acid, 2,4-dideoxy-3,5-O-(1-methylethylidene)-
- CAS:
- 154877-92-6
- MF:
- C9H16O5
- Structure:
- Chemical Name:
- Linagliptin Dimer impurity (N-C-C-C Dimer)Q: What is Linagliptin Dimer impurity (N-C-C-C Dimer) Q: What is the CAS Number of Linagliptin Dimer impurity (N-C-C-C Dimer)
- CAS:
- 2463617-49-2
- MF:
- C51H56N16O4
- Structure:
- Chemical Name:
- Benzoic acid, 4-[(1,3-dihydro-1-hydroxy-2,1-benzoxaborol-5-yl)oxy]-
- CAS:
- 906673-43-6
- MF:
- C14H11BO5
- Structure:
- Chemical Name:
- Benzenemethanamine, α,α'-sulfonylbis(methylene)bis[3-ethoxy-4-methoxy-
- CAS:
- 2417213-71-7
- MF:
- C22H32N2O6S
- Structure:
- Chemical Name:
- 1H-Purine-2,6-dione, 8-(3-amino-1-piperidinyl)-7-(3-chloro-2-buten-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-
- CAS:
- 2138805-26-0
- MF:
- C25H29ClN8O2
- Structure:
- Chemical Name:
- 1,3-Benzenedicarboxamide, 5-[acetyl(2,3-dihydroxypropyl)amino]-N1,N3-bis(2,3-dihydroxypropyl)-2,4-diiodo-
- CAS:
- 1651211-78-7
- MF:
- C19H27I2N3O9
- Chemical Name:
- (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxy-3-ethylbenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol
- Chemical Name:
- (E)-1-(4-(2-carboxyvinyl)benzyl)-1H-imidazole 3-oxide
- Chemical Name:
- Aprepitant impurity 2
- Chemical Name:
- Aprepitant impurity 4
- Chemical Name:
- Vonoprazan Impurity B-2
- Structure:
- Chemical Name:
- 2-(Cyanomethylthio)acetic acid
- CAS:
- 55817-29-3
- MF:
- C4H5NO2S
- Structure:
- Chemical Name:
- 2(1H)-Pyridinone, 1-(3-aminophenyl)-5,6-dihydro-3-(4-morpholinyl)-
- CAS:
- 2437650-75-2
- MF:
- C15H19N3O2
- Structure:
- Chemical Name:
- 4(1H)-Pyridinone, 1-(6-methoxy-1H-benzimidazol-2-yl)-2,3,5-trimethyl-
- CAS:
- 2512216-37-2
- MF:
- C16H17N3O2
- Chemical Name:
- Budesonide Impurity 31
- Chemical Name:
- Budesonide Impurity 23
- Structure:
- Chemical Name:
- Hexanoic acid, 3-(chloromethyl)-, (3R)-
- CAS:
- 2101641-90-9
- MF:
- C7H13ClO2
- Structure:
- Chemical Name:
- Bisoprolol Impurity
- CAS:
- 2226263-68-7
- MF:
- C18H31NO4
- Structure:
- Chemical Name:
- 2(1H)-Quinolinone, 5-[(1R)-1,2-dihydroxyethyl]-8-(phenylmethoxy)-
- CAS:
- 1261219-83-3
- MF:
- C18H17NO4
- Structure:
- Chemical Name:
- Tofacitinib Impurity
- CAS:
- 2504210-41-5
- MF:
- C29H38N10O2
- Structure:
- Chemical Name:
- 2-Pentenoic acid, 3-amino-2-cyano-5-[(3R,4R)-4-methyl-3-(methyl-7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-1-piperidinyl]-5-oxo-, ethyl ester, (2E)-
- CAS:
- 2459302-85-1
- MF:
- C21H27N7O3
- Chemical Name:
- Avatrombopag Impurity 38
- Structure:
- Chemical Name:
- (1S,1'S,2S,2'S)-2,2'-((pentane-1,5-diylbis(oxy))bis(3-oxopropane-3,1-diyl))bis(1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinolin-2-ium)
- CAS:
- 96946-55-3
- MF:
- C53H72N2O12+2
- Structure:
- Chemical Name:
- (R)-N-Glycidylphthalimide
- CAS:
- 181140-34-1
- MF:
- C11H9NO3
- Structure:
- Chemical Name:
- 6-chloro-N-((1R,2S)-2-(3,4-difluorophenyl)cyclopropyl)-5- nitro-2-(propylthio)pyrimidin-4-amine
- CAS:
- 1427523-93-0
- MF:
- C16H15ClF2N4O2S
- Chemical Name:
- Bendamustine Impurity 15
- Chemical Name:
- Bendamustine Related Impurity 10
- Chemical Name:
- Bortezomib Impurity 16
- Structure:
- Chemical Name:
- Captopril Related Compound 8
- CAS:
- 112243-88-6
- MF:
- C9H15NO3S
- Chemical Name:
- Edoxaban Impurity 25 (1R,2S,4R) Oxalate
- Structure:
- Chemical Name:
- Ezetimibe Impurity 35
- CAS:
- 1650568-82-3
- MF:
- C39H46F2N2O5Si2
- Chemical Name:
- Fosaprepitant Impurity 8
- Structure:
- Chemical Name:
- Linagliptin Impurity 28
- CAS:
- 2074688-84-7
- MF:
- C22H23N7O3
- Chemical Name:
- Pantoprazole Impurity 3
- Chemical Name:
- Ticagrelor Related Compound 58
- Chemical Name:
- Vildagliptin Impurity 9
- Structure:
- Chemical Name:
- Cefathiamidine Impurity 5
- CAS:
- 40818-86-8
- MF:
- C10H11ClN2O4S
- Structure:
- Chemical Name:
- methyl 4-hydroxy-3,5-diisopropylbenzoic acid
- MF:
- C14H20O3
- Chemical Name:
- Apixaban Impurity J
- Chemical Name:
- Avibactam Impurity C
- Chemical Name:
- Brexpiprazole Impurity M
- Chemical Name:
- Cefaclor Impurity 5
- Chemical Name:
- Linagliptin Impurity 39
- Chemical Name:
- Peramivir Impurity 5
- Chemical Name:
- Pidotimod Impurity O
- Chemical Name:
- Pramipexole EP Impurity C
- Structure:
- Chemical Name:
- Imiquimod Impurity 5
- CAS:
- 853793-02-9
- MF:
- C15H18N4
- Structure:
- Chemical Name:
- Vonoprazan Fumarate Impurity 6
- CAS:
- 2250243-23-1
- MF:
- C33H27F2N5O4S2
- Structure:
- Chemical Name:
- 3-((3aS,4R,6S,6aR)-6-(2-hydroxyethoxy)-2,2-dimethyltetrahydro- 4H-cyclopenta[d][1,3]dioxol-4-yl)-5-(propylthio)-3H-[1,2,3] triazolo[4,5-d]pyrimidin-7-ol
- CAS:
- 1456538-51-4
- MF:
- C17H25N5O5S
- Chemical Name:
- Esomeprazole Impurity 24
- Chemical Name:
- Prasugrel Impurity 15
- Structure:
- Chemical Name:
- Pregabalin Impurity 18
- CAS:
- 1621171-19-4
- MF:
- C9H15NO2
- Chemical Name:
- Pregabalin Impurity 23
- Structure:
- Chemical Name:
- Butylphthalide impurity
- CAS:
- 16692-58-3
- MF:
- C12H14O2
- Structure:
- Chemical Name:
- ethyl 2,5-dihydroxybenzenesulfonate
- MF:
- C8H10O5S
- Structure:
- Chemical Name:
- 5-ALLYLIDENE-10,11-DIHYDRO-5H-DIBENZO[A,D]CYCLOHEPTENE
- CAS:
- 24755-73-5
- MF:
- C18H16
- Structure:
- Chemical Name:
- tert-butyl (4-(benzyloxy)-8-methylnaphthalen-2-yl)carbamate
- CAS:
- 1662687-76-4
- MF:
- C23H25NO3
- Chemical Name:
- Nintedanib Impurity 27
- Structure:
- Chemical Name:
- ethyl 2-(2-formyl-3-hydroxyphenyl)-4-methylthiazole-5- carboxylate
- MF:
- C14H13NO4S
- Structure:
- Chemical Name:
- LUMAT-004
- CAS:
- 313544-31-9
- MF:
- C16H17N3O3
- Structure:
- Chemical Name:
- Varenicline Impurity 3
- CAS:
- 1333145-89-3
- MF:
- C14H15N3
- Structure:
- Chemical Name:
- Econazole Related Compound C (15 mg) (1-(4-Chlorobenzyl)-3-[(2RS)-2-[(4-chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]imidazolium chloride)
- CAS:
- 57265-33-5
- Structure:
- Chemical Name:
- Amlodipine Impurity 22 (Z-Isomer)
- MF:
- C26H31ClN2O8S
- Structure:
- Chemical Name:
- Amlodipine Impurity 28
- CAS:
- 79781-21-8
- MF:
- C18H20ClNO5
- Chemical Name:
- Axitinib Impurity 16
- Chemical Name:
- Axitinib Impurity 22
- Structure:
- Chemical Name:
- Imidazo[5,1-f][1,2,4]triazin-4(1H)-one, 2-[2-ethoxy-5-[(4-ethyl-4-oxido-1-piperazinyl)sulfonyl]phenyl]-5-methyl-7-propyl-
- CAS:
- 448184-48-3
- MF:
- C23H32N6O5S
- Structure:
- Chemical Name:
- Dolutegravir 4-Desfluoro Impurity
- CAS:
- 1863916-87-3
- MF:
- C20H20FN3O5
- Structure:
- Chemical Name:
- Tetrabenazine Dehydro Impurity
- CAS:
- 100322-43-8
- MF:
- C19H25NO3