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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- Structure:
- Chemical Name:
- bromobenzarone
- CAS:
- 94729-09-6
- MF:
- C17H13BrO3
- Chemical Name:
- Oprinone Impurity 3
- Structure:
- Chemical Name:
- digoxigenin-bis(digitoxoside)
- CAS:
- 5297-05-2
- MF:
- C35H54O11
- Structure:
- Chemical Name:
- 17 alpha-cyanomethyl-19-nortestosterone
- CAS:
- 67473-36-3
- MF:
- C20H27NO2
- Structure:
- Chemical Name:
- desmethylazelastine
- CAS:
- 47491-38-3
- MF:
- C21H22ClN3O
- Structure:
- Chemical Name:
- 8-hydroxyclomipramine
- CAS:
- 83385-97-1
- MF:
- C19H23ClN2O
- Structure:
- Chemical Name:
- Ro 15-3505
- CAS:
- 78756-33-9
- MF:
- C15H14ClN3O3
- Structure:
- Chemical Name:
- L 683519
- CAS:
- 132172-14-6
- MF:
- C43H67NO12
- Structure:
- Chemical Name:
- benzylpenicilloic acid
- CAS:
- 13057-98-2
- MF:
- C16H20N2O5S
- Structure:
- Chemical Name:
- erythralosamine
- CAS:
- 546-57-6
- MF:
- C29H49NO8
- Structure:
- Chemical Name:
- HYDROXYMETHYL CELECOXIB
- CAS:
- 170571-00-3
- MF:
- C17H14F3N3O3S
- Structure:
- Chemical Name:
- 2-(2-cyanophenyl)benzonitrile
- CAS:
- 4341-02-0
- MF:
- C14H8N2
- Structure:
- Chemical Name:
- 6-methylprednisone
- CAS:
- 91523-05-6
- MF:
- C22H28O5
- Structure:
- Chemical Name:
- ETHYL (1R,5R,6R)-5-(1-ETHYLPROPOXY)-7-AZABICYCLO[4.1.0]HEPT-3-ENE-3-CARBOXYLATE
- CAS:
- 204255-02-7
- MF:
- C14H23NO3
- Structure:
- Chemical Name:
- 2-(4-HYDROXY-PHENYL)-4-METHYL-THIAZOLE-5-CARBOXYLIC ACID
- CAS:
- 886501-78-6
- MF:
- C11H9NO3S
- Structure:
- Chemical Name:
- 2-Methyl-4-nitro-1H-imidazole-1-acetic acid
- CAS:
- 16230-87-8
- MF:
- C6H7N3O4
- Structure:
- Chemical Name:
- Benzofuran-5-carboxylic acid
- CAS:
- 90721-27-0
- MF:
- C9H6O3
- Structure:
- Chemical Name:
- 7-Chloro-1,6,7,8-tetradeoxy-6-[[[(2S)-1-methyl-4β-propyl-2α-pyrrolidinyl]carbonyl]amino]-1-(methylsulfinyl)-α-L-threo-D-galacto-octopyranose
- CAS:
- 22431-46-5
- MF:
- C18H33ClN2O6S
- Structure:
- Chemical Name:
- (1,1-DIOXIDO-3-OXO-1,2-BENZISOTHIAZOL-2(3H)-YL)ACETIC ACID
- CAS:
- 52188-11-1
- MF:
- C9H7NO5S
- Structure:
- Chemical Name:
- Celebrex Carboxylic Acid Methyl Ester
- CAS:
- 1189893-75-1
- MF:
- C18H14F3N3O4S
- Structure:
- Chemical Name:
- (S)-BoroLeu-(-)-Pinanediol-hydrochloride
- CAS:
- 945606-99-5
- MF:
- C15H29BClNO2
- Structure:
- Chemical Name:
- N-(2,4-dimethylphenyl)piperidine-2-carboxamide
- CAS:
- 99552-32-6
- MF:
- C14H20N2O
- Structure:
- Chemical Name:
- pyrrolidinyl)-, (2β,3α,5α,16β,17β)-
- CAS:
- 144209-33-6
- MF:
- C27H46N2O2
- Structure:
- Chemical Name:
- (4S,6S)-6-[2-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-1,3-dioxane-4-acetic Acid 1,1-Dimethylethyl Ester
- CAS:
- 472967-95-6
- MF:
- C40H47FN2O5
- Structure:
- Chemical Name:
- 6a-Methylprednisone 21-Acetate
- CAS:
- 115321-98-7
- MF:
- C24H30O6
- Structure:
- Chemical Name:
- Aztreonam Amide
- CAS:
- 1219444-93-5
- MF:
- C13H20N6O8S2
- Structure:
- Chemical Name:
- N'-[(2Z)-Piperazin-2-ylidene]trifluoroacetohydrazide
- CAS:
- 763105-70-0
- MF:
- C6H9F3N4O
- Structure:
- Chemical Name:
- HERBACETIN-3,8-DIGLUCOPYRANOSIDE
- CAS:
- 99224-12-1
- MF:
- C27H30O17
- Structure:
- Chemical Name:
- (3R,5R)-Fluvastatin Sodium Salt
- CAS:
- 194934-99-1
- MF:
- C24H27FNNaO4
- Structure:
- Chemical Name:
- Orlistat Dihydropyranone Impurity
- CAS:
- 130676-64-1
- MF:
- C22H40O2
- Structure:
- Chemical Name:
- Orlistat Dihydropyranone Impurity
- CAS:
- 130676-64-1
- MF:
- C22H40O2
- Structure:
- Chemical Name:
- 2-(Propylthio)-4(1H)-pyrimidinone
- CAS:
- 54460-95-6
- MF:
- C7H10N2OS
- Structure:
- Chemical Name:
- BROMOSULBACTAM
- CAS:
- 75527-87-6
- MF:
- C8H10BrNO5S
- Structure:
- Chemical Name:
- (S)-PYRROLIDINE-2-CARBONITRILE
- CAS:
- 204387-53-1
- MF:
- C5H8N2
- Structure:
- Chemical Name:
- 1-(CHLOROACETYL)-L-PROLINE METHYL ESTER
- CAS:
- 38074-72-5
- MF:
- C8H12ClNO3
- Structure:
- Chemical Name:
- 1-(4-PIPERIDINYLCARBONYL)-4-PIPERIDINECARBOXYLIC ACID
- CAS:
- 96053-48-4
- MF:
- C12H20N2O3
- Structure:
- Chemical Name:
- 1-(3-PYRIDYL)ETHAN-1-ONE OXIME
- CAS:
- 5973-83-1
- MF:
- C7H8N2O
- Structure:
- Chemical Name:
- 1-(3,4,5-Trimethoxy-benzyl)-piperazinedihydrochloride
- CAS:
- 107049-57-0
- MF:
- C14H24Cl2N2O3
- Structure:
- Chemical Name:
- Sitagliptin N-Sulfate
- CAS:
- 940002-57-3
- MF:
- C16H15F6N5O4S
- Structure:
- Chemical Name:
- 1-Oxo Mirtazapine (Mirtazapine Impurity C)
- CAS:
- 191546-96-0
- MF:
- C17H17N3O
- Structure:
- Chemical Name:
- (3S,4S)-3-Hexyl-4-[(S)-2-hydroxytridecyl]-2-oxetanone
- CAS:
- 68711-40-0
- MF:
- C22H42O3
- Structure:
- Chemical Name:
- N-(2,6-Dimethylphenyl)-2-(ethylmethylamino)acetamide Hydrochloride_x000b_(Lidocaine Impurity E)
- CAS:
- 50295-20-0
- MF:
- C13H21ClN2O
- Structure:
- Chemical Name:
- ent-Cinacalcet Hydrochloride
- CAS:
- 694495-47-1
- MF:
- C22H22F3N
- Structure:
- Chemical Name:
- Nsc529487
- CAS:
- 3310-47-2
- MF:
- C9H13N3O6
- Structure:
- Chemical Name:
- Oxathiolan 5fu-.B.
- CAS:
- 145986-11-4
- MF:
- C8H9FN2O4S
- Structure:
- Chemical Name:
- Decarboxy Enrofloxacin
- CAS:
- 131775-99-0
- MF:
- C18H22FN3O
- Structure:
- Chemical Name:
- Desethanol Dipyridamole
- CAS:
- 1176886-12-6
- MF:
- C22H36N8O3
- Structure:
- Chemical Name:
- 2’’-Desethyl-2’’-vinyl Simvastatin
- CAS:
- 1449248-72-9
- MF:
- C25H36O5
- Structure:
- Chemical Name:
- 1,2-Dihydro Dexamethasone
- CAS:
- 426-17-5
- MF:
- C22H31FO5
- Structure:
- Chemical Name:
- Lamotrigine N2-Oxide
- CAS:
- 136565-76-9
- MF:
- C9H7Cl2N5O
- Structure:
- Chemical Name:
- 4-[3-(Methylamino)-1-(2-thienyl)propyl]-
- CAS:
- 949096-01-9
- MF:
- C18H20BrNOS
- Structure:
- Chemical Name:
- N-Isopropyl Carvedilol
- CAS:
- 1246819-01-1
- MF:
- C27H32N2O4
- Structure:
- Chemical Name:
- 5-Oxo Atorvastatin
- CAS:
- 1391052-82-6
- MF:
- C33H33FN2O5
- Structure:
- Chemical Name:
- 1-Methyl-12-thioxopyrido[1,2,3,4]imidazole-[1,2-a]benzimidazole-2(12H)-one
- CAS:
- 1246819-06-6
- MF:
- C14H9N3OS
- Structure:
- Chemical Name:
- N-(3-AMINOPROPYL)DIETHANOLAMINE
- CAS:
- 4985-85-7
- MF:
- C7H18N2O2
- Structure:
- Chemical Name:
- 2-Methylpropaneboronic acid (1S,2S,3R,5S)-(+)-2,3-pinanediol ester
- CAS:
- 84110-34-9
- MF:
- C14H25BO2
- Structure:
- Chemical Name:
- Mirtazapine N-Oxide
- CAS:
- 155172-12-6
- MF:
- C17H19N3O
- Structure:
- Chemical Name:
- 3-Oxo Citalopram
- CAS:
- 372941-54-3
- MF:
- C20H19FN2O2
- Structure:
- Chemical Name:
- Quetiapine N-Oxide
- CAS:
- 1076199-40-0
- MF:
- C21H25N3O3S
- Structure:
- Chemical Name:
- EthanediaMide, N1-(5-chloro-2-pyridinyl)-N2-[(1R,2S,4S)-4-[(diMethylaMino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-Methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]aMino]cyclohexyl]-
- CAS:
- 1255529-25-9
- MF:
- C24H30ClN7O4S
- Structure:
- Chemical Name:
- N-((3R,4R)-1-benzyl-4-Methylpiperidin-3-yl)-2-chloro-N-Methyl-7H-pyrrolo[2,3-d]pyriMidin-4-aMine
- CAS:
- 923036-25-3
- MF:
- C20H24ClN5
- Structure:
- Chemical Name:
- 8-Chloro-11-(piperidin-4-ylidene)-11H-benzo[5,6]cyclohepta[1,2-b]pyridine
- CAS:
- 117811-20-8
- MF:
- C19H17ClN2
- 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
- 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
- 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:
- 1-(4-methoxyphenyl)-2-methylpropan-2-amine
- CAS:
- 56490-94-9
- MF:
- C11H17NO
- Chemical Name:
- product/153101
- Structure:
- Chemical Name:
- 2-Methyl-5,6-dihydro-4H-benzo[b]oxazolo[5,4-d]azepine
- CAS:
- 877858-27-0
- MF:
- C12H12N2O
- 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
- Chemical Name:
- Topiroxostat IMpurity
- Structure:
- Chemical Name:
- Flurbiprofen Impurity 17
- CAS:
- 1206101-29-2
- MF:
- C24H16F2
- Structure:
- Chemical Name:
- Azilsartan Impurity
- CAS:
- 1586011-04-2
- MF:
- C26H25N3O4
- Structure:
- Chemical Name:
- 1,2-Bis(piperazin-1-yl)benzene
- CAS:
- 1446750-99-7
- MF:
- C14H22N4