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:
- Org246653-1(RRT0.35)
- Structure:
- Chemical Name:
- 1H-Isoindole-1,3(2H)-dione, 2-[(2S)-2,3-dihydroxypropyl]-
- CAS:
- 119835-88-0
- MF:
- C11H11NO4
- Structure:
- Chemical Name:
- Brexpiprazole Impurity 76
- CAS:
- 433303-94-7
- MF:
- C12H14N2S
- Structure:
- Chemical Name:
- Phenacetin Impurity 3
- CAS:
- 24176-84-9
- MF:
- C14H13ClN2O2
- Structure:
- Chemical Name:
- 2-(isopropylamino)-3-(4-(2-methoxyethyl)phenoxy)propan-1-ol
- CAS:
- 109632-11-3
- MF:
- C15H25NO3
- Chemical Name:
- Pabuxilibu impurities
- Chemical Name:
- ERYTHROMYCIN IMPURITY G
- Chemical Name:
- Amylmetacresol EP impurity E
- Structure:
- Chemical Name:
- (2S)-2-(2,5-dioxo-3-propylpyrrolidin-1-yl)butanamide
- CAS:
- 2232201-72-6
- MF:
- C11H18N2O3
- Structure:
- Chemical Name:
- methyl 1-hydroxy-2-oxoindoline-6-carboxylate
- CAS:
- 1895918-24-7
- MF:
- C10H9NO4
- Chemical Name:
- Dapagliflozin Impurity (MW: 437Da)
- Chemical Name:
- Cetirizine Impurity BHA
- Chemical Name:
- Macitentandesbromopyrimidine Impurity
- Chemical Name:
- Cilastatin EP Impurity H
- Structure:
- Chemical Name:
- Febuxostat Impurity 130
- CAS:
- 1643131-93-4
- MF:
- C20H25NO5S
- Chemical Name:
- (2-Chlorophenyl)diphenylmethanol
- Structure:
- Chemical Name:
- Nilotinib Impurity 27
- CAS:
- 1807606-80-9
- MF:
- C28H22F3N7O2
- Structure:
- Chemical Name:
- Juncusol 2-O-glucoside
- CAS:
- 175094-14-1
- MF:
- C24H28O7
- Structure:
- Chemical Name:
- Homovanillyl alcohol 4-O-glucoside
- CAS:
- 104380-15-6
- MF:
- C15H22O8
- Structure:
- Chemical Name:
- (6R,9R)-3-Oxo-α-ionol glucoside
- CAS:
- 77699-19-5
- MF:
- C19H30O7
- Structure:
- Chemical Name:
- Myricetin 3,7,3'-trimethyl ether 5'-O-glucoside
- CAS:
- 2170444-56-9
- MF:
- C24H26O13
- Chemical Name:
- Vonoprazan Impurity 53
- Chemical Name:
- Vonoprazan Impurity 61
- Chemical Name:
- Emtricitabine Ring-opening Impurity
- Chemical Name:
- Tafluprost Impurity 1 (Tafluprost (1S,2S,3S,5R)-Isomer)
- Structure:
- Chemical Name:
- Escitalopram Butyryl Impurity
- CAS:
- 1803244-58-7
- MF:
- C25H33FN2O2
- Structure:
- Chemical Name:
- Osimertinib Impurity N
- CAS:
- 1932710-29-6
- MF:
- C31H35N7O3
- Chemical Name:
- Oseltamivir isomer impurity
- Structure:
- Chemical Name:
- Ethyl 4-bromo-3-hydroxybutyrate
- CAS:
- 32224-01-4
- MF:
- C6H11BrO3
- Structure:
- Chemical Name:
- Ethanol, 2-[[2-amino-2-(3-ethoxy-4-methoxyphenyl)ethyl]sulfonyl]-
- CAS:
- 2733250-84-3
- MF:
- C13H21NO5S
- Structure:
- Chemical Name:
- 8-chloro-6-fluoro-1-((1R,2S)-2-fluorocyclopropyl)-7-hydroxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
- CAS:
- 2365490-44-2
- MF:
- C13H8ClF2NO4
- Structure:
- Chemical Name:
- [3-[[[2-(Diaminomethyleneamino)-4-thiazolyl]methyl]thio]propionyl]sulfamide
- CAS:
- 106433-44-7
- MF:
- C8H14N6O3S3
- Structure:
- Chemical Name:
- 3-Formyl-25-desacetyl Rifamycin
- CAS:
- 16783-97-4
- MF:
- C36H45NO12
- Structure:
- Chemical Name:
- 4-(3-Methylphenyl)-2H-pyrido[4,3-e]-1,2,4-thiadiazin-3(4H)-one 1,1-Dioxide
- CAS:
- 72810-61-8
- MF:
- C13H11N3O3S
- Structure:
- Chemical Name:
- 8-Desacetyl-8-carboxy Daunorubicin Hydrochloride
- CAS:
- 58199-96-5
- MF:
- C26H27NO11.ClH
- Structure:
- Chemical Name:
- D,L N,O-Didesmethylvenlafaxine
- CAS:
- 135308-74-6
- MF:
- C15H23NO2
- Structure:
- Chemical Name:
- Desmethyl Erlotinib Acetate
- CAS:
- 183320-15-2
- MF:
- C23H23N3O5
- Structure:
- Chemical Name:
- Erythromycin E_x000b_Discontinued
- CAS:
- 41451-91-6
- MF:
- C37H65NO14
- Structure:
- Chemical Name:
- 1,2-Benzenedicarboxylic acid, 3-amino-, 2-ethyl ester
- CAS:
- 1822756-03-5
- MF:
- C10H11NO4
- Structure:
- Chemical Name:
- 1,2-Benzenedicarboxylic acid, 3-amino-, 2-ethyl ester
- CAS:
- 1822756-03-5
- MF:
- C10H11NO4
- Structure:
- Chemical Name:
- 2-(3,4-dihydroxyphenyl)acetaldehyde
- CAS:
- 5707-55-1
- MF:
- C8H8O3
- Structure:
- Chemical Name:
- NSC 77154
- CAS:
- 4121-39-5
- MF:
- C8H9N5
- Structure:
- Chemical Name:
- N-Methyl-N,N-bis(2-pyridylethyl)amine
- CAS:
- 5452-87-9
- MF:
- C15H19N3
- Chemical Name:
- Benazepril Related Compound F
- Structure:
- Chemical Name:
- 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, (2S-trans)-
- CAS:
- 111188-70-6
- MF:
- C22H26N2O4S
- Structure:
- Chemical Name:
- 1H-Benzimidazole-2-sulfinicacid(9CI)
- CAS:
- 58536-71-3
- MF:
- C7H6N2O2S
- Structure:
- Chemical Name:
- 1(3H)-Isobenzofuranone,3-methyl-(9CI)
- CAS:
- 3453-64-3
- MF:
- C9H8O2
- Chemical Name:
- Oprinone Impurity 5
- Chemical Name:
- Oprinone Impurity 2
- Chemical Name:
- (R)-Cilastatin EP Impurity G
- Structure:
- Chemical Name:
- 3-ETHOXY-4-METHOXYBENZOIC ACID
- CAS:
- 2651-55-0
- MF:
- C10H12O4
- Structure:
- Chemical Name:
- 4-hydroxyurapidil
- CAS:
- 88733-12-4
- MF:
- C20H29N5O4
- Structure:
- Chemical Name:
- 2-chloro-4-nitrophenyl-N-acetylglucosaminide
- CAS:
- 103614-82-0
- MF:
- C14H17ClN2O8
- Chemical Name:
- Imimidistine impurity D
- Chemical Name:
- Afatinib impurity 84
- Chemical Name:
- Sugammadex sodium Impurity 40
- Chemical Name:
- Sugammadex sodium Impurity 44
- Chemical Name:
- Sugammadex sodium Impurity 49
- Chemical Name:
- Cefazolin Impurity EP-E
- Chemical Name:
- Canagliflozin Impurity 70
- Chemical Name:
- Dapoxetine impurity 66
- Chemical Name:
- EP Impurity Catalog
- Structure:
- Chemical Name:
- Pentanoic acid, 3-(bromomethyl)-4-methyl-, ethyl ester, (3S)-
- CAS:
- 2432911-38-9
- MF:
- C9H17BrO2
- Structure:
- Chemical Name:
- 2-Pyrrolidinone, 3-ethylidene-, (Z)- (8CI)
- CAS:
- 930-93-8
- MF:
- C6H9NO
- Structure:
- Chemical Name:
- Imidazo[5,1-f][1,2,4]triazin-4(1H)-one, 2-[5-[(4-ethyl-1-piperazinyl)sulfonyl]-2-hydroxyphenyl]-5-methyl-7-propyl-
- CAS:
- 2411340-39-9
- MF:
- C21H28N6O4S
- Structure:
- Chemical Name:
- 3-Azetidineacetonitrile, 1-(ethylsulfonyl)-3-[4-[7-(hydroxymethyl)-7H-pyrrolo[2,3-d]pyrimidin-4-yl]-1H-pyrazol-1-yl]-
- CAS:
- 1187595-89-6
- MF:
- C17H19N7O3S
- Structure:
- Chemical Name:
- 4-methyl-N-(2-(methylamino)phenyl)-2-propyl-1H-benzo[d]imidazole-6-carboxamide
- CAS:
- 884330-18-1
- MF:
- C19H22N4O
- Structure:
- Chemical Name:
- Benzeneacetic acid, 3-(2-amino-1,1-dimethyl-2-oxoethyl)-α,α-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-
- CAS:
- 2469244-33-3
- MF:
- C17H22N4O3
- Structure:
- Chemical Name:
- 2,4(1H,3H)-Pyrimidinedione, 5-(2-fluoro-3-methoxyphenyl)-1-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-3-[(2R)-2-(hydroxyamino)-2-phenylethyl]-6-methyl-
- CAS:
- 2486454-64-0
- MF:
- C28H24F5N3O4
- Structure:
- Chemical Name:
- 3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-hydroxyphenyl)amino]-6-hydroxy-7-[3-(4-methyl-1-piperazinyl)propoxy]-
- CAS:
- 2468737-94-0
- MF:
- C24H25Cl2N5O3
- Structure:
- Chemical Name:
- 1H-Pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxaline, 2,3,6b,7,8,9,10,10a-octahydro-, (6bR,10aS)-
- CAS:
- 313368-81-9
- MF:
- C13H17N3
- Structure:
- Chemical Name:
- Ergoline-8-methanol, 1,6-dimethyl-, (8β)- (9CI)
- CAS:
- 40170-12-5
- MF:
- C17H22N2O
- Chemical Name:
- Avatrombopag Impurity 22
- Chemical Name:
- Avatrombopag Impurity 33
- Chemical Name:
- Cisatracurium besylate impurity 16
- Structure:
- Chemical Name:
- 1-ACETYL-2-METHYLBENZIMIDAZOLE
- CAS:
- 14678-81-0
- MF:
- C10H10N2O
- Structure:
- Chemical Name:
- (E)-3-(2-Formylphenyl)-2-propenoic acid 1,1-dimethyl ethyl ester
- CAS:
- 103890-69-3
- MF:
- C14H16O3
- Structure:
- Chemical Name:
- 1H-Dibenz[e,g]indole-1-heptanoic acid, 9-fluoro-2,3-dihydro-β,δ-dihydroxy-3-(1-methylethyl)-2-oxo-3-[(phenylamino)carbonyl]-, (βR,δR)-
- CAS:
- 1046533-62-3
- MF:
- C33H33FN2O6
- Chemical Name:
- Bimatoprost Impurity 22
- Chemical Name:
- Bumetanide Impurity 9
- Chemical Name:
- Crisaborole Impurity 14
- Structure:
- Chemical Name:
- desisopropylprocaterol
- CAS:
- 63483-95-4
- MF:
- C13H16N2O3
- Structure:
- Chemical Name:
- 10-bromocarbamazepine
- CAS:
- 59690-97-0
- MF:
- C15H11BrN2O
- Structure:
- Chemical Name:
- ethyl apovincaminate
- CAS:
- 42971-12-0
- MF:
- C22H26N2O2
- Structure:
- Chemical Name:
- ALS 8123
- CAS:
- 81148-15-4
- MF:
- C15H23NO4
- Structure:
- Chemical Name:
- Ro 14-7437
- CAS:
- 78756-03-3
- MF:
- C15H15N3O3
- Structure:
- Chemical Name:
- 4-(2-Cyanophenyl)benzaldehyde
- CAS:
- 135689-93-9
- MF:
- C14H9NO
- Structure:
- Chemical Name:
- 2-(N,N-DIETHYLAMINO)-4,6-DICHLOROTRIAZINE
- CAS:
- 2401-64-1
- MF:
- C5H6Cl2N4
- Structure:
- Chemical Name:
- (S)-4-Chloro-1,3-butanediol
- CAS:
- 139013-68-6
- MF:
- C4H9ClO2
- Structure:
- Chemical Name:
- 6-CHLORO-1-METHYLURACIL
- CAS:
- 31737-09-4
- MF:
- C5H5ClN2O2
- Structure:
- Chemical Name:
- 5-(Propylthio)-1H-benzimidazol-2-amine
- CAS:
- 80983-36-4
- MF:
- C10H13N3S
- Structure:
- Chemical Name:
- Ethyl 4,5-bis(2-methoxyethoxy)-2-nitrobenzoate
- CAS:
- 179688-26-7
- MF:
- C15H21NO8
- Structure:
- Chemical Name:
- Hexyl methanesulfonate
- CAS:
- 16156-50-6
- MF:
- C7H16O3S
- Structure:
- Chemical Name:
- 5-CHLOROTHIOPHENE-3-CARBOXYLIC ACID
- CAS:
- 36157-42-3
- MF:
- C5H3ClO2S
- Structure:
- Chemical Name:
- (S)-(+)-1-[(4-Chlorophenyl)phenylmethyl]piperazine
- CAS:
- 439858-21-6
- MF:
- C17H19ClN2
- Structure:
- Chemical Name:
- 2,8-Dichloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-β]pyridin-11-one
- CAS:
- 133330-61-7
- MF:
- C14H9Cl2NO
- Structure:
- Chemical Name:
- 2-Isopropyl-6-propylphenol (Propofol Impurity O)
- CAS:
- 74663-48-2
- MF:
- C12H18O
- Structure:
- Chemical Name:
- 3-Methyl-2-(3,4-dimethoxyphenyl)butyronitrile
- CAS:
- 20850-49-1
- MF:
- C13H17NO2
- Structure:
- Chemical Name:
- N-methyl-N-(4-nitrophenyl)-2-(piperazin-1-yl)acetamide
- CAS:
- 1038972-16-5
- MF:
- C13H18N4O3
- Structure:
- Chemical Name:
- 1,4-BIS[3,4-DIHYDRO-2(1H)-QUINOLINON-7-OXY]BUTANE
- CAS:
- 882880-12-8
- MF:
- C22H24N2O4