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:
- Edoxaban Impurity 11
- Structure:
- Chemical Name:
- Empagliflozin Impurity 5
- CAS:
- 1800196-46-6
- MF:
- C17H16ClIO3
- Chemical Name:
- Carfilzomib Impurity 2
- Structure:
- Chemical Name:
- Oseltamivir Impurity 20
- CAS:
- 212504-90-0
- MF:
- C12H22N2O3
- Chemical Name:
- Febuxostat Impurity 61
- Chemical Name:
- Atosiban Impurity G
- Structure:
- Chemical Name:
- 1-cyclopropyl-6,8-dimethoxy-7-((4aS,7aS)-octahydro-6H-pyrrolo [3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic
- CAS:
- 2252446-68-5
- MF:
- C22H28ClN3O5
- Structure:
- Chemical Name:
- CINACALCET-001-R
- CAS:
- 1630761-22-6
- MF:
- C11H11BF4N4O
- Chemical Name:
- Cefotiam Impurity D
- Structure:
- Chemical Name:
- Atorvastatin Calcium Hydrate impurity 39
- CAS:
- 2243639-97-4
- MF:
- C33H35FN2O5
- Chemical Name:
- Peramivir Impurity B
- Chemical Name:
- AztreonaM IMpurity C
- Structure:
- Chemical Name:
- Pramipexole Related Impurity 3
- CAS:
- 2166216-34-6
- MF:
- C10H17N3OS
- Chemical Name:
- Lincomycin sulfoxide Impurity 5
- Chemical Name:
- Sulpiride Impurity 4
- Chemical Name:
- Tacrolimus Impurity E
- Chemical Name:
- Bumetanide iMpurity E
- Chemical Name:
- Labetalol EP impurity E
- Structure:
- Chemical Name:
- 4,6-DIAMINOINDAZOLE
- CAS:
- 885518-52-5
- MF:
- C7H8N4
- Structure:
- Chemical Name:
- 12-Deoxy Roxithromycin
- CAS:
- 425365-65-7
- MF:
- C41H76N2O14
- Structure:
- Chemical Name:
- 1-(1-oxidopyridin-1-ium-2-yl)-1-phenylethanol
- CAS:
- 100393-43-9
- MF:
- C13H13NO2
- Structure:
- Chemical Name:
- (R)-(R)-1-methylpyrrolidin-3-yl 2-cyclopentyl-2-hydroxy-2-phenylacetate(WXC03446)
- CAS:
- 616866-21-8
- MF:
- C18H25NO3
- Structure:
- Chemical Name:
- (R)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzoic acid
- MF:
- C18H22N4O4
- Structure:
- Chemical Name:
- 6'-methyl-3-(4-(methylsulfonyl)phenyl)-[2,3'-bipyridin]-5-amine
- MF:
- C18H17N3O2S
- Chemical Name:
- Diquafosol Impurity 4
- Chemical Name:
- Tofacitinib Impurity X
- Structure:
- Chemical Name:
- 3-pentylideneisobenzofuran-1(3H)-one
- CAS:
- 90965-68-7
- MF:
- C13H14O2
- Structure:
- Chemical Name:
- 1-Propanol, 3-(2-methoxy-5-nitrophenoxy)-
- CAS:
- 1156068-41-5
- MF:
- C10H13NO5
- Structure:
- Chemical Name:
- 1616710-52-1
- CAS:
- 1616710-52-1
- MF:
- C27H34N2O6
- Structure:
- Chemical Name:
- 8-Chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-one
- CAS:
- 31251-41-9
- MF:
- C14H10ClNO
- Structure:
- Chemical Name:
- (R)-Ornidazole
- CAS:
- 166734-80-1
- MF:
- C7H10ClN3O3
- Chemical Name:
- Bendamustine Related Impurity 22
- Chemical Name:
- Bendamustine Related Impurity 9
- Structure:
- Chemical Name:
- Edoxaban Impurity 20 (1R,2R,4S)
- CAS:
- 1928729-31-0
- MF:
- C16H29N3O7
- Structure:
- Chemical Name:
- Edoxaban Impurity 40
- CAS:
- 2081883-52-3
- MF:
- C14H27N3O3
- Chemical Name:
- Everolimus Impurity 2
- Structure:
- Chemical Name:
- Apixaban Impurity 22
- CAS:
- 1449510-64-8
- MF:
- C25H26ClN5O4
- Chemical Name:
- Cefdinir impurity TU mixture
- Chemical Name:
- Fotagliptin Impurity 1
- Chemical Name:
- Rocuronium bromide Impurity 7
- Chemical Name:
- Tofacitinib Impurity 69
- Structure:
- Chemical Name:
- Benzenamine, 3-(2-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)-
- CAS:
- 641571-06-4
- MF:
- C11H10F3N3
- Structure:
- Chemical Name:
- Ciprofloxacin EP Impurity E
- CAS:
- 879005-96-6
- MF:
- C16H20FN3O
- Structure:
- Chemical Name:
- ethyl 2-(3-cyano-4-propoxyphenyl)-4-methylthiazole-5- carboxylate
- MF:
- C17H18N2O3S
- Structure:
- Chemical Name:
- (2S,5R,6S)-6-bromo-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid Diphenylmethyl Ester
- CAS:
- 74189-25-6
- MF:
- C21H20BrNO3S
- Structure:
- Chemical Name:
- Trelagliptin Impurity 5
- CAS:
- 2087874-92-6
- MF:
- C22H24FN5O5
- Structure:
- Chemical Name:
- 9H-Purin-6-amine, 9-beta-D-arabinofuranosyl-2-methoxy-
- CAS:
- 51742-84-8
- MF:
- C11H15N5O5
- Structure:
- Chemical Name:
- 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylic acid 1-oxide
- CAS:
- 2418591-42-9
- MF:
- C16H16N2O4S
- Structure:
- Chemical Name:
- Ropivacaine impurity
- CAS:
- 1786841-18-6
- MF:
- C12H14N2O3
- Structure:
- Chemical Name:
- (E)-4-BROMO-N,N-DIMETHYLBUT-2-ENAMIDE
- CAS:
- 137131-09-0
- MF:
- C6H10BrNO
- Structure:
- Chemical Name:
- Almotriptan Impurity 1
- CAS:
- 334981-13-4
- MF:
- C17H25N3O3S
- Structure:
- Chemical Name:
- Amlodipine Impurity 33
- MF:
- C26H31ClN2O8S
- Chemical Name:
- Erlotinib Impurity 36 HCl
- Structure:
- Chemical Name:
- Rasagiline Impurity 6 HCl
- CAS:
- 138911-07-6
- MF:
- C9H11NO
- Structure:
- Chemical Name:
- Cefmetazole Lactone
- CAS:
- 70993-70-3
- MF:
- C13H13N3O5S2
- Chemical Name:
- Canagliflozin Impurity 19
- Chemical Name:
- Canagliflozin Impurity 24
- Chemical Name:
- Carfilzomib Impurity 5
- Structure:
- Chemical Name:
- Dolutegravir Impurity 6
- CAS:
- 1357289-29-2
- MF:
- C20H19F2N3O5
- Chemical Name:
- Febuxostat Impurity 22
- Chemical Name:
- Istradefylline Impurity C
- Structure:
- Chemical Name:
- Everolimus O-Ethyl Impurity
- CAS:
- 1704711-12-5
- MF:
- C54H85NO14
- Structure:
- Chemical Name:
- (3S,4R)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-1-methyl-4-phenylpiperidine
- CAS:
- 324023-99-6
- MF:
- C20H23NO3
- Structure:
- Chemical Name:
- Solifenacin Impurity 4（Solifenacin EP Impurity H）
- CAS:
- 732228-02-3
- MF:
- C23H26N2O2
- Structure:
- Chemical Name:
- 849217-77-2
- CAS:
- 849217-77-2
- MF:
- C22H20N2O6
- Structure:
- Chemical Name:
- 1-Piperidinepropanoic acid, 4-methyl-3-(methyl-7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-β-oxo-, ethyl ester, (3R,4R)-
- CAS:
- 1675248-18-6
- MF:
- C18H25N5O3
- Structure:
- Chemical Name:
- Amlodipine iMpurity L
- CAS:
- 1821498-25-2
- MF:
- C17H19ClN2O5
- Structure:
- Chemical Name:
- (6R,7R)-7-[(2,2-dimethylpropanoyl)amino]-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)sulfanyl]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
- CAS:
- 2384108-14-7
- MF:
- C16H20N4O4S3
- Structure:
- Chemical Name:
- methyl (41R,12R,13aS)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate
- CAS:
- 58000-63-8
- MF:
- C21H26N2O3
- Structure:
- Chemical Name:
- (S)-ethyl 2-(((S)-(perfluorophenoxy)(phenoxy)phosphoryl)amino)propanoate
- CAS:
- 1392015-05-2
- MF:
- C17H15F5NO5P
- Structure:
- Chemical Name:
- N-(2-(dimethylamino)-4-methoxy-5-((4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl)amino)phenyl)acrylamide
- CAS:
- 2044702-39-6
- MF:
- C25H26N6O2
- Structure:
- Chemical Name:
- 3-(2-cyclopentylidene-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-ium bromide
- MF:
- C19H26BrNO2
- Structure:
- Chemical Name:
- Apixaban Impurity 16
- CAS:
- 1619934-76-7
- MF:
- C31H37N5O6
- Structure:
- Chemical Name:
- Cephalexin Impurity 3
- MF:
- C16H17N3O4S
- Structure:
- Chemical Name:
- (6R,7R)-3-(((5-methyl-1,3,4-thiadiazol-2-yl)thio)methyl)-8-oxo-7-pivalamido-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
- CAS:
- 1798390-48-3
- MF:
- C16H20N4O4S3
- Structure:
- Chemical Name:
- 2-chloromethyl-4-(3-hydroxypropoxy)-3-methylpyridine
- CAS:
- 117976-92-8
- MF:
- C10H14ClNO2
- Structure:
- Chemical Name:
- 8-Methoxy Entecavir
- CAS:
- 2203740-23-0
- MF:
- C13H17N5O4
- Structure:
- Chemical Name:
- Bortezomib Impurity 32
- CAS:
- 1310383-72-2
- MF:
- C17H31BF3NO5
- Chemical Name:
- Topiroxostat Impurity 14
- Structure:
- Chemical Name:
- 1-Pyrrolidinecarboxylic acid, 4-hydroxy-2-(3-thiazolidinylcarbonyl)-, 1,1-dimethylethyl ester, (2S,4S)-
- CAS:
- 401564-34-9
- MF:
- C13H22N2O4S
- Chemical Name:
- Ampicillin Impurity B
- Chemical Name:
- Clindamycin Phosphate EP Impurity K
- Structure:
- Chemical Name:
- UGDFSHGFPJSALM-OCKHKDLRSA-N
- CAS:
- 113806-01-2
- MF:
- C22H25NO3
- Structure:
- Chemical Name:
- Homoeriodictyol 7-O-glucoside
- CAS:
- 14982-11-7
- MF:
- C22H24O11
- Structure:
- Chemical Name:
- 7,7'-(butane-1,4-diylbis(oxy))bis(quinolin-2(1H)-one)
- CAS:
- 2116542-19-7
- MF:
- C22H20N2O4
- Chemical Name:
- Levosimendan Impurity 2 (Mixture ofZandEIsomers)
- Structure:
- Chemical Name:
- N-(2,3-Dichloro-phenyl)-N'-[2-(2,3-dichloro-phenylamino)-ethyl]-ethane-1,2-diamine
- MF:
- C16H17Cl4N3
- Structure:
- Chemical Name:
- Solifenacin Related Compound 29
- CAS:
- 861998-77-8
- MF:
- C23H26N2O3
- Chemical Name:
- Ticagrelor Impurity 31
- Structure:
- Chemical Name:
- Ticagrelor Related Compound 46
- CAS:
- 2205903-73-5
- MF:
- C28H42ClN9O8S2
- Structure:
- Chemical Name:
- Ticagrelor Related Compound 71
- CAS:
- 1548397-10-9
- MF:
- C7H8ClN3O3S
- Chemical Name:
- Ticagrelor Related Compound 76
- Chemical Name:
- Vonoprazan Impurity 25
- Structure:
- Chemical Name:
- 1-(3,4-Dimethoxyphenyl)-2-(methylsulfonyl)ethan-1-amine
- CAS:
- 1255909-25-1
- MF:
- C11H17NO4S
- Chemical Name:
- Adefovir Impurity C
- Chemical Name:
- Blonanserin Impurity M
- Chemical Name:
- Brexpiprazole Impurity H
- Chemical Name:
- Cefaclor EP Impurity H
- Chemical Name:
- Flupentixol Impurity B
- Structure:
- Chemical Name:
- Ipratropium Bromide Impurity J
- MF:
- C20H29Br2NO3