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.
- Structure:
- Chemical Name:Lercanidipine Impurity 6
- CAS:786625-22-7
- MF:C37H43N3O6
- Chemical Name:Linagliptin Impurity 43
- CAS:
- MF:
- Chemical Name:MiraBegron Impurity A
- CAS:
- MF:
- Chemical Name:Moxifloxacin Impurity 15
- CAS:
- MF:
- Chemical Name:Moxifloxacin Impurity 32
- CAS:
- MF:
- Structure:
- Chemical Name:Nifedipine Impurity F
- CAS:53055-15-5
- MF:C18H20N2O6
- Structure:
- Chemical Name:Olaparib Impurity 15
- CAS:2250243-17-3
- MF:C24H25FN4O3
- Structure:
- Chemical Name:Olopatadine Impurity 4
- CAS:55690-15-8
- MF:C18H18O5
- Chemical Name:Posaconazole Impurity 26
- CAS:
- MF:
- Structure:
- Chemical Name:Posaconazole Impurity 48
- CAS:1902954-03-3
- MF:C37H42F2N8O5
- Chemical Name:Posaconazole Impurity 9
- CAS:
- MF:
- Chemical Name:Roxithromycin Impurity E
- CAS:
- MF:
- Chemical Name:SofosBuvir impurity 48
- CAS:
- MF:
- Structure:
- Chemical Name:SofosBuvir Impurity 54
- CAS:1431932-81-8
- MF:C12H17ClNO4P
- Structure:
- Chemical Name:Timolol EP Impurity G
- CAS:75202-36-7
- MF:C6H9N3O3S
- Structure:
- Chemical Name:Tofacitinib Impurity 44
- CAS:2374700-39-5
- MF:C13H19N5
- Chemical Name:Trelagliptin Impurity 24
- CAS:
- MF:
- Structure:
- Chemical Name:dimethyl 3- isobutylpentanedioate
- CAS:145328-03-6
- MF:C11H20O4
- Structure:
- Chemical Name:7-Methoxy-4-oxo-1,4-dihydroquinoline-6-carboxylic acid
- CAS:417721-34-7
- MF:C11H9NO4
- Chemical Name:Pemetrexed
- CAS:
- MF:
- Structure:
- Chemical Name:Venlafaxine
- CAS:
- MF:C17H27NO2
- Structure:
- Chemical Name:(R)-3-((R)-5-(4-fluorophenyl)-5-hydroxypentanoyl)-4-phenyloxazolidin-2-one
- CAS:1612153-32-8
- MF:C20H20FNO4
- Structure:
- Chemical Name:(S)-3-((R)-5-(4-fluorophenyl)-5-hydroxypentanoyl)-4-phenyloxazolidin-2-one
- CAS:528565-93-7
- MF:C20H20FNO4
- Chemical Name:Posaconazole iMpurity 3
- CAS:
- MF:
- Structure:
- Chemical Name:Bezafibrate Impurity D
- CAS:41859-58-9
- MF:C21H24ClNO4
- Structure:
- Chemical Name:Cloxacillin Sodium EP Impurity B (Mixture of Diastereomers)
- CAS:1642559-64-5
- MF:C18H20ClN3O4S
- Structure:
- Chemical Name:Ezetimibe Related Impurity 37
- CAS:204589-68-4
- MF:C24H19F2NO2
- Structure:
- Chemical Name:S, R-Isovalganciclovir Impurity
- CAS:1356932-18-7
- MF:C14H22N6O5
- Structure:
- Chemical Name:Sofosbuvir Impurity 8
- CAS:944476-44-2
- MF:C24H22N2O8
- Structure:
- Chemical Name:135270-13-2
- CAS:135270-13-2
- MF:C12H11F2N3O
- Structure:
- Chemical Name:1-((2'-cyanobiphenyl-4-yl)methyl)-4-methyl-2-propyl-1H-benzo[d]imidazole-6-carboxylic acid
- CAS:1098100-87-8
- MF:C26H23N3O2
- Chemical Name:Fimasartan Impurity
- CAS:
- MF:
- Structure:
- Chemical Name:2-(((5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)methyl)(methyl)amino)succinic acid
- CAS:
- MF:C21H20FN3O6S
- Structure:
- Chemical Name:()-Olivil 4″-O-glucoside
- CAS:76880-93-8
- MF:C26H34O12
- Structure:
- Chemical Name:2-(DIETHYLAMINO)-N-(2,4-DIMETHYLPHENYL)ACETAMIDE
- CAS:17289-53-1
- MF:C14H22N2O
- Structure:
- Chemical Name:Phenol, 4-chloro-3-[(4-ethoxyphenyl)methyl]-
- CAS:1408077-50-8
- MF:C15H15ClO2
- Structure:
- Chemical Name:2-amino-9-((3aS,4S,6S,6aR)-3a,6-dihydroxyhexahydro-1H-cyclopenta[c]furan-4-yl)-1,9-dihydro-6H-purin-6-one
- CAS:1984788-96-6
- MF:C12H15N5O4
- Chemical Name:Ampicillin Impurity C
- CAS:
- MF:
- Chemical Name:Ampicillin Impurity O
- CAS:
- MF:
- Chemical Name:mixture of PD 312236 and PD 312237
- CAS:
- MF:
- Structure:
- Chemical Name:Axitinib Impurity 27
- CAS:1639137-80-6
- MF:C24H20N4O2S
- Structure:
- Chemical Name:(4R,5R,6S)-4-nitrobenzyl 6-((R)-1-hydroxyethyl)-4-methyl-3,7-dioxo-1-azabicyclo[3.2.0]heptane-2-carboxylate
- CAS:104873-15-6
- MF:C17H18N2O7
- Chemical Name:Lesinurad Impurity
- CAS:
- MF:
- Structure:
- Chemical Name:Chrysophanol triglucoside
- CAS:120181-07-9
- MF:C33H40O19
- Structure:
- Chemical Name:7H-Pyrazolo[4,3-d]pyrimidin-7-one, 5-(5-chloro-2-ethoxyphenyl)-1,6-dihydro-1-methyl-3-propyl-
- CAS:1829588-57-9
- MF:C17H19ClN4O2
- Chemical Name:Cefminox sodium impurities Ⅲ
- CAS:
- MF:
- Structure:
- Chemical Name:Canagliflozin Impurity 18
- CAS:1951467-29-0
- MF:C24H25FO6S
- Structure:
- Chemical Name:Fosaprepitant Impurity 6
- CAS:327623-34-7
- MF:C21H19F6NO3
- Structure:
- Chemical Name:Ivabradine Impurity 16 HCl
- CAS:304464-98-0
- MF:C26H34N2O5
- Chemical Name:Moxifloxacin EP Impurity A HCl
- CAS:
- MF:
- Structure:
- Chemical Name:Paroxetine EP Impurity H HCl
- CAS:503834-41-1
- MF:C19H23ClFNO
- Structure:
- Chemical Name:Solifenacin Related Compound 13
- CAS:1251905-45-9
- MF:C17H17NO2
- Structure:
- Chemical Name:1-(3-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-carboximidamide
- CAS:2101651-50-5
- MF:C14H12FN5
- Structure:
- Chemical Name:N1-(4-chlorophenyl)-3,12-diimino-N14-phenyl-2,4,11,13-Tetraazatetradecanediimidamide
- CAS:152504-12-6
- MF:C22H31ClN10
- Structure:
- Chemical Name:Palonosetron
- CAS:135729-56-5
- MF:C19H22N2O
- Structure:
- Chemical Name:Fludarabine Phosphate iMpurity B
- CAS:149297-79-0
- MF:C5H5N5O
- Structure:
- Chemical Name:nifedipine iMpurity C
- CAS:111304-31-5
- MF:C12H11NO5
- Structure:
- Chemical Name:RofluMilast related substance
- CAS:475271-62-6
- MF:C16H14Cl2N2O3
- Structure:
- Chemical Name:Ritonavir EP Impurity I
- CAS:165315-26-4
- MF:C36H46N6O5S2
- Structure:
- Chemical Name:(6R-trans)-7-[(2,2-diMethyl-1-oxopropyl)aMino]-3-Methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-
- CAS:146794-70-9
- MF:C13H18N2O4S
- Structure:
- Chemical Name:3-[3-[[[(7S)-3,4-DiMethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]Methyl]MethylaMino]propyl]-1,3-dihydro-7,8-diMethoxy-H-3-benzazepin-2-one
- CAS:1086026-31-4
- MF:C27H34N2O5
- Structure:
- Chemical Name:7-[(3R)-3-[(N-Acetyl)AMino]-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoroMethyl)-1,2,4-triazolo[4,3-a]pyrazine
- CAS:1379666-94-0
- MF:C18H17F6N5O2
- Structure:
- Chemical Name:2-[[Methyl[(3S)-3-(1-naphthalenyloxy)-3-(2-thienyl)propyl]aMino]carbonyl]benzoic Acid
- CAS:199191-67-8
- MF:C26H23NO4S
- Structure:
- Chemical Name:Labetalol IMpurity B
- CAS:802620-01-5
- MF:C20H25NO4
- Structure:
- Chemical Name:Ritonavir EP Impurity C
- CAS:1010808-43-1
- MF:C25H29N3O4S
- Structure:
- Chemical Name:AcetaMide, N,N-bis[2-(7-Methoxy-1-naphthalenyl)ethyl]-
- CAS:1385018-58-5
- MF:C28H29NO3
- Structure:
- Chemical Name:(S)-quinuclidin-3-aMine
- CAS:120570-05-0
- MF:C7H14N2
- Structure:
- Chemical Name:Benzene, 1-chloro-2-nitroso-
- CAS:932-33-2
- MF:C6H4ClNO
- Structure:
- Chemical Name:AMoxicillin IMpurity G
- CAS:
- MF:C16H19N3O5S
- Structure:
- Chemical Name:IMp. A (EP): Ethyl 4-[(11RS)-8-Chloro-11-hydroxy-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-yl]piperidine-1-carboxylate
- CAS:38092-95-4
- MF:C19H20N2
- Structure:
- Chemical Name:PeMetrexed EP IMpurity E
- CAS:182009-04-7
- MF:C20H21N5O6
- Chemical Name:Itraconazole iMpurity A
- CAS:
- MF:
- Structure:
- Chemical Name:(S)-BoroLeu-(-)-Pinanediol-CF3COOH
- CAS:477254-69-6
- MF:C17H29BF3NO4
- Structure:
- Chemical Name:Butanedioic acid, 2,3-dihydroxy- (2R,3R)-, MonoMethyl ester
- CAS:3333-46-8
- MF:C5H8O6
- Structure:
- Chemical Name:Valsartan D9
- CAS:1089736-73-1
- MF:C24H29N5O3
- Structure:
- Chemical Name:N-((3S,4S)-1-benzyl-4-Methylpiperidin-3-yl)-N-Methyl-7H-pyrrolo[2,3-d]pyriMidin-4-aMine
- CAS:1252883-90-1
- MF:C20H25N5
- Structure:
- Chemical Name:P219490
- CAS:937370-10-0
- MF:C20H21N5Na2O6**
- Structure:
- Chemical Name:(S)-4-(TERT-BUTOXY)-2-ISOPROPYL-4-OXOBUTANOIC ACID
- CAS:134807-43-5
- MF:C11H20O4
- Structure:
- Chemical Name:Acarbose D-Fructose IMpurity
- CAS:1013621-79-8
- MF:C25H43NO18
- Structure:
- Chemical Name:2,4,6,8-Tetraoxa-5-phosphanonanedioic acid, 5-[[(1R)-2-(6-aMino-9H-purin-9-yl)-1-Methylethoxy]Methyl]-, 1-ethyl 9-(1-Methylethyl) ester, 5-oxide
- CAS:1422284-16-9
- MF:C18H28N5O10P
- Structure:
- Chemical Name:(R)-α-[2-(1-naphthalenyloxy)ethyl]-benzeneMethanol
- CAS:156453-53-1
- MF:C19H18O2
- Structure:
- Chemical Name:4-[4-(diMethylaMino)-1-(4-fluorophenyl)-1-buten-1-yl]-3-(hydroxyMethyl)-benzonitrile (CitalopraM Olefinic IMpurity)
- CAS:920282-75-3
- MF:C20H21FN2O
- Structure:
- Chemical Name:2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy)ethyl Acetate
- CAS:844639-07-2
- MF:C23H27N3O3S
- Structure:
- Chemical Name:4-O-DesMethyl 4-O-Ethyl TriMethopriM
- CAS:78025-68-0
- MF:C15H20N4O3
- Structure:
- Chemical Name:1-[[(2E)-3-Phenyl-2-propen-1-yl]oxy]naphthalene
- CAS:1091626-77-5
- MF:C19H16O
- Structure:
- Chemical Name:α-[[[2-(4-Methoxyphenyl)-1-Methylethyl](phenylMethyl)aMino]Methyl]-3-nitro-4-(phenylMethoxy)benzeneMethanol
- CAS:43229-67-0
- MF:C32H34N2O5
- Structure:
- Chemical Name:Indacaterol IMrity
- CAS:1235445-80-3
- MF:C24H28N2O3
- Structure:
- Chemical Name:(S)-4,5-dichloro-N-((2-oxo-3-(4-(3-oxoMorpholino)phenyl)oxazolidin-5-yl)Methyl)thiophene-2-carboxaMide
- CAS:1770812-37-7
- MF:C19H17Cl2N3O5S
- Structure:
- Chemical Name:2-Propen-1-one, 1-[4-[4-aMino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyriMidin-1-yl]-1-piperidinyl]-
- CAS:936563-92-7
- MF:C25H24N6O2
- Structure:
- Chemical Name:8-cyclopentyl-5-Methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)aMino)-6-vinylpyrido[2,3-d]pyriMidin-7(8H)-one
- CAS:
- MF:C24H29N7O
- Structure:
- Chemical Name:D-Alanine, N-[[P(R),2'R]-2'-deoxy-2'-fluoro-2'-Methyl-P-phenyl-5'-uridylyl]-, 1-Methylethyl ester
- CAS:1496552-16-9
- MF:C22H29FN3O9P
- Structure:
- Chemical Name:D-Phenylalanine, N-[(1,1-diMethylethoxy)carbonyl]-L-leucyl-, Methyl ester
- CAS:15136-32-0
- MF:C21H32N2O5
- Structure:
- Chemical Name:4-Nitro-2-phenoxyphenol
- CAS:70995-08-3
- MF:C12H9NO4
- Structure:
- Chemical Name:Sofosbuvir Impurity
- CAS:1233335-82-4
- MF:C16H25FN3O9P
- Structure:
- Chemical Name:Ethyl 3,4-O-isopropylideneshikiMate
- CAS:136994-78-0
- MF:C12H18O5
- Structure:
- Chemical Name:4-Vinyl-piperidine-4-carboxylic acid ethyl ester
- CAS:1509910-91-1
- MF:C10H17NO2
- Structure:
- Chemical Name:(2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-aMino-2-Methylpentanoic acid
- CAS:1039307-95-3
- MF:C18H21NO2
- Chemical Name:EMpagliflozin iMpurity 16
- CAS:
- MF:
- Structure:
- Chemical Name:((R)-2-biphenyl-4-yl-1-forMylethyl)carbaMic acid t-butyl ester
- CAS:149709-58-0
- MF:C20H23NO3
- Structure:
- Chemical Name:1-(2,3-DiMethylphenyl)-1-(1H-iMidazol-4-yl)ethanol
- CAS:86347-12-8
- MF:C13H16N2O