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:
- 3-METHOXY-DL-TYROSINE
- CAS:
- 7636-26-2
- MF:
- C10H13NO4
- Structure:
- Chemical Name:
- 4-(DIPHENYLMETHOXY)PIPERIDINE
- CAS:
- 58258-01-8
- MF:
- C18H21NO
- Structure:
- Chemical Name:
- BETA-ESTRADIOL 17-ACETATE
- CAS:
- 1743-60-8
- MF:
- C20H26O3
- Structure:
- Chemical Name:
- N,N'-Dipropylurea
- CAS:
- 623-95-0
- MF:
- C7H16N2O
- Structure:
- Chemical Name:
- Fenoxanil
- CAS:
- 115852-48-7
- MF:
- C15H18Cl2N2O2
- Structure:
- Chemical Name:
- MCPB
- CAS:
- 94-81-5
- MF:
- C11H13ClO3
- Structure:
- Chemical Name:
- BHC
- CAS:
- 608-73-1
- MF:
- C6H6Cl6
- Structure:
- Chemical Name:
- ISOPRENALINE SULFATE
- CAS:
- 6700-39-6
- MF:
- 2C11H17NO3.2H2O.H2O4S
- Structure:
- Chemical Name:
- 4-BENZOYLOXY-TEMPO
- CAS:
- 3225-26-1
- MF:
- C16H22NO3*
- Structure:
- Chemical Name:
- Spectinomycin sulfate tetrahydrate
- CAS:
- 64058-48-6
- MF:
- C14H26N2O11S
- Structure:
- Chemical Name:
- ACETYLSALICYLSALICYLIC ACID
- CAS:
- 530-75-6
- MF:
- C16H12O6
- Structure:
- Chemical Name:
- 1,1-DICHLOROPROPENE
- CAS:
- 563-58-6
- MF:
- C3H4Cl2
- Structure:
- Chemical Name:
- BENTRANIL
- CAS:
- 1022-46-4
- MF:
- C14H9NO2
- Structure:
- Chemical Name:
- EPN
- CAS:
- 2104-64-5
- MF:
- C14H14NO4PS
- Structure:
- Chemical Name:
- 2-AMINO-4,6-DINITROTOLUENE
- CAS:
- 35572-78-2
- MF:
- C7H7N3O4
- Structure:
- Chemical Name:
- 3-AMINO-2-OXAZOLIDINONE
- CAS:
- 80-65-9
- MF:
- C3H6N2O2
- Structure:
- Chemical Name:
- DIHYDROERGOCRISTINE MESYLATE
- CAS:
- 24730-10-7
- MF:
- C36H45N5O8S
- Structure:
- Chemical Name:
- AFLATOXIN M1
- CAS:
- 6795-23-9
- MF:
- C17H12O7
- Structure:
- Chemical Name:
- ALDICARB-SULFONE
- CAS:
- 1646-88-4
- MF:
- C7H14N2O4S
- Structure:
- Chemical Name:
- CARBOFURAN-3-HYDROXY
- CAS:
- 16655-82-6
- MF:
- C12H15NO4
- Structure:
- Chemical Name:
- Dinitramine
- CAS:
- 29091-05-2
- MF:
- C11H13F3N4O4
- Structure:
- Chemical Name:
- Pyributicarb
- CAS:
- 88678-67-5
- MF:
- C18H22N2O2S
- Structure:
- Chemical Name:
- N-DESMETHYLCLOZAPINE
- CAS:
- 6104-71-8
- MF:
- C17H17ClN4
- Structure:
- Chemical Name:
- PENTACHLOROANISOLE
- CAS:
- 1825-21-4
- MF:
- C7H3Cl5O
- Chemical Name:
- Soybean Flour
- CAS:
- 68513-95-1
- Structure:
- Chemical Name:
- 2,3,4,5-TETRACHLOROPHENOL
- CAS:
- 4901-51-3
- MF:
- C6H2Cl4O
- Structure:
- Chemical Name:
- Terbacil
- CAS:
- 5902-51-2
- MF:
- C9H13ClN2O2
- Structure:
- Chemical Name:
- BROMOPRIDE
- CAS:
- 4093-35-0
- MF:
- C14H22BrN3O2
- Structure:
- Chemical Name:
- MEPENZOLATE BROMIDE
- CAS:
- 76-90-4
- MF:
- C21H26BrNO3
- Structure:
- Chemical Name:
- 3,4,5-TRICHLOROPHENOL
- CAS:
- 609-19-8
- MF:
- C6H3Cl3O
- Structure:
- Chemical Name:
- 6-METHYLCHRYSENE
- CAS:
- 1705-85-7
- MF:
- C19H14
- Structure:
- Chemical Name:
- Tris(2,3-dibromopropyl)phosphate
- CAS:
- 126-72-7
- MF:
- C9H15Br6O4P
- Structure:
- Chemical Name:
- Chlordecone
- CAS:
- 143-50-0
- MF:
- C10Cl10O
- Structure:
- Chemical Name:
- METHYSTICIN
- CAS:
- 495-85-2
- MF:
- C15H14O5
- Structure:
- Chemical Name:
- QUINMERAC
- CAS:
- 90717-03-6
- MF:
- C11H8ClNO2
- Structure:
- Chemical Name:
- 4-CARBOXY-2,2,6,6-TETRAMETHYLPIPERIDINE 1-OXYL
- CAS:
- 37149-18-1
- MF:
- C10H18NO3*
- Structure:
- Chemical Name:
- 1-Cyanocyclohexaneacetic acid
- CAS:
- 133481-09-1
- MF:
- C9H13NO2
- Structure:
- Chemical Name:
- 2,4,6-TRI-TERT-BUTYLNITROSOBENZENE
- CAS:
- 24973-59-9
- MF:
- C18H29NO
- Structure:
- Chemical Name:
- 2,4-DIAMINO-6-DIMETHYLAMINO-1,3,5-TRIAZINE
- CAS:
- 1985-46-2
- MF:
- C5H10N6
- Structure:
- Chemical Name:
- 2,4,5-TRICHLOROTOLUENE
- CAS:
- 6639-30-1
- MF:
- C7H5Cl3
- Structure:
- Chemical Name:
- NEOERIOCITRIN
- CAS:
- 13241-32-2
- MF:
- C27H32O15
- Structure:
- Chemical Name:
- (3aS-cis)-1,3-dibenzyltetrahydro-1H-thieno[3,4-d]imidazole-2,4-dione
- CAS:
- 28092-52-6
- MF:
- C19H18N2O2S
- Chemical Name:
- L-Cefadroxil Impurity F(EP)
- Structure:
- Chemical Name:
- methyl L-prolinate
- CAS:
- 2577-48-2
- MF:
- C6H11NO2
- Chemical Name:
- sodium (S,Z)-2-((1S,2R)-1-carboxylato-2-hydroxypropyl)-5-(4- hydroxybutylidene)-2,5-dihydrothiazole-4-carboxylate
- Chemical Name:
- 3-(((3R)-3-((R)-1-(3,5-bis(trifluoromethyl)phenyl)ethoxy)-2-(4-fluorophenyl)-1,4-dioxan-2-ylamino)methyl)-1H-1,2,4-triazol-5(4H)-one
- Structure:
- Chemical Name:
- 2,4,6-tripropyl-1,3,5-trioxane
- CAS:
- 2396-43-2
- MF:
- C12H24O3
- Chemical Name:
- Oseltamivir Impurity 94
- Chemical Name:
- Oseltamivir Impurity 82
- Chemical Name:
- Oseltamivir Impurity 74
- Structure:
- Chemical Name:
- Uridine, 5'-(2-methylpropanoate) (9CI)
- CAS:
- 886538-48-3
- MF:
- C13H18N2O7
- Chemical Name:
- Dapagliflozin Impurity 47
- Chemical Name:
- Crisaborole Impurity 17
- Chemical Name:
- Crisaborole Impurity 19
- Structure:
- Chemical Name:
- D(-)-AMETHOPTERIN
- CAS:
- 51865-79-3
- MF:
- C20H22N8O5
- Structure:
- Chemical Name:
- Glycine, N-(2-aminobenzoyl)-, ethyl ester
- CAS:
- 5973-34-2
- MF:
- C11H14N2O3
- Structure:
- Chemical Name:
- 6-Chloro-3,4-dihydro-4-methyl-3-oxo-2H-1,4-benzoxanine-8-carboxylic acid
- CAS:
- 123040-79-9
- MF:
- C10H8ClNO4
- Structure:
- Chemical Name:
- 3-Amino-3-azabicyclo[3.3.0]octane
- CAS:
- 54528-00-6
- MF:
- C7H14N2
- Structure:
- Chemical Name:
- (S)-Methyl 2-aminobutanoate
- CAS:
- 15399-22-1
- MF:
- C5H11NO2
- Structure:
- Chemical Name:
- 1,5-Pentanedione, 1-(2-fluorophenyl)-5-[(4S)-2-oxo-4-phenyl-3-oxazolidinyl]-
- CAS:
- 2514695-40-8
- MF:
- C20H18FNO4
- Structure:
- Chemical Name:
- 4-ethoxy-3-(4-pyridyl)-3-buten-2-one
- CAS:
- 88349-61-5
- MF:
- C11H13NO2
- Structure:
- Chemical Name:
- 1,3-dihydro-4-methyl-2H-1,5-benzodiazepin-2-one
- CAS:
- 6276-48-8
- MF:
- C10H10N2O
- Structure:
- Chemical Name:
- (E)-2-methoxy-4-(prop-1-enyl)phenol
- CAS:
- 5932-68-3
- MF:
- C10H12O2
- Structure:
- Chemical Name:
- 3-amino-5-[(methylthio)methyl]oxazolidin-2-one
- CAS:
- 25517-72-0
- MF:
- C5H10N2O2S
- Structure:
- Chemical Name:
- Phosphonic acid, [[2-(6-amino-9H-purin-9-yl)propoxy]methyl]- (9CI)
- CAS:
- 107021-20-5
- MF:
- C9H14N5O4P
- Chemical Name:
- Sitagliptin EP Impurity 7
- Chemical Name:
- Sitagliptin EP Impurity H
- Structure:
- Chemical Name:
- 7-Benzofurancarboxamide, 4-amino-5-chloro-2,3-dihydro-3-hydroxy-N-[1-(3-methoxypropyl)-4-piperidinyl]-
- CAS:
- 2636673-48-6
- MF:
- C18H26ClN3O4
- Chemical Name:
- Beprostatin impurity 4
- Structure:
- Chemical Name:
- cis-5-chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole
- CAS:
- 65621-78-5
- MF:
- C17H16ClNO
- Structure:
- Chemical Name:
- methyl tosylcarbamate
- CAS:
- 14437-03-7
- MF:
- C9H11NO4S
- Structure:
- Chemical Name:
- (1R,2R,4S,5S,7s,9r)-9-butyl-9-methyl-7-((2-phenylacryloyl)oxy)-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-9-ium
- CAS:
- 786598-71-8
- MF:
- C21H28NO3+
- Structure:
- Chemical Name:
- (+)-2-Ethoxy-4-(N-3-Methyl-1(S)-(2-(1-Piperidinyl)Phenyl)-Butyl)Carbamoylmethyl)
- CAS:
- 147770-06-7
- MF:
- C29H40N2O4
- Structure:
- Chemical Name:
- 4-Chloro-2-(chloromethyl)-3-Methyl Pyridine Hydrochloride
- CAS:
- 152402-97-6
- MF:
- C7H8Cl3N
- Structure:
- Chemical Name:
- 4-(3-CYANO-2-METHYLPROPIONYL)ACETAMILIDE
- CAS:
- 42075-21-8
- Structure:
- Chemical Name:
- Erythromycin, 6-O-Methyl-2',4'-Bis-O-(Trimethylsilyl)-, 9-[O-(1-Methoxy-1-Methylethyl)Oxime]
- CAS:
- 119699-81-9
- MF:
- C48H94N2O14Si2
- Chemical Name:
- (R)-8-(3-aminopiperidin-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-7-(3-oxobutyl)-3,7-dihydro-1H-purine-2,6-dione
- Chemical Name:
- Isavuconazole Impurity 37
- Structure:
- Chemical Name:
- N-((R)-1-(((R)-3-methyl-1-((3aS,4S,6S,7aR)-3a,5,5-trimethylhexahydro-4,6-methanobenzo[d][1,3,2]dioxaborol-2-yl)butyl)amino)-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxamide
- CAS:
- 1375004-39-9
- MF:
- C29H39BN4O4
- Chemical Name:
- (S)-1-(2-(((1r,3R,5S,7S)-3,5-dihydroxyadamantan-1-yl)amino)acetyl)pyrrolidine-2-carbonitrile
- Chemical Name:
- Mannitol EP impurity B
- Chemical Name:
- Mannitol EP impurity A
- Chemical Name:
- Peramivir Amino Carboxylic Isomerism Impurity
- Chemical Name:
- Peramivir Chlorinated Impurity
- Chemical Name:
- Brivaracetam Impurity 999
- Chemical Name:
- Dasatinib impurity 48
- Chemical Name:
- Pemetrexed Impurity 120
- Chemical Name:
- 1-(3-((2,4-dimethylphenyl)thio)phenyl)piperazine hydrochloride
- CAS:
- 2137793-92-9
- Chemical Name:
- Apixaban impurity 66S
- Structure:
- Chemical Name:
- Aatrombopag Impurity 17
- CAS:
- 1268118-96-2
- MF:
- C7H4BrClN2S2
- Structure:
- Chemical Name:
- (R)-(-)-2-AMINOBUTANAMIDE HYDROCHLORIDE, 97%
- CAS:
- 103765-03-3
- MF:
- C4H11ClN2O
- Structure:
- Chemical Name:
- Flomoxef Impurity 20 Sodium Salt
- CAS:
- 2095697-77-9
- MF:
- C15H18F2N6O7S2
- Structure:
- Chemical Name:
- (Z)-3-(4-((1H-imidazol-1-yl)methyl)phenyl)acrylic acid
- CAS:
- 883903-90-0
- MF:
- C13H13N2NaO2
- Structure:
- Chemical Name:
- ((2R,3S,4R)-3,4,5-trihydroxytetrahydrofuran-2-yl)methyl isobutyrate
- CAS:
- 2591381-21-2
- MF:
- C9H16O6
- Structure:
- Chemical Name:
- 3-Thiophenecarboxylic acid, 4-(bromomethyl)-2-[[(2,6-difluorophenyl)methyl](propoxycarbonyl)amino]-5-(4-nitrophenyl)-, ethyl ester
- CAS:
- 2591260-07-8
- MF:
- C25H23BrF2N2O6S
- Structure:
- Chemical Name:
- Cyclohexanecarboxylic acid, 2-[[[4-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]butyl]amino]carbonyl]-, (1R,2S)-rel-
- CAS:
- 190582-37-7
- MF:
- C23H32N4O3S
- Chemical Name:
- Ivabradine Impurity II
- Structure:
- Chemical Name:
- (1R,2R,4S,5S,7r)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl 2-hydroxy-2,2-di(thiophen-2-yl)acetate
- CAS:
- 792155-94-3
- MF:
- C18H19NO4S2