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:
- Bisoprolol Impurity 40
- Structure:
- Chemical Name:
- 2H-Naphtho[1,2-b]pyran-6-ol, 2,5-dimethyl-2-[(3E,7E)-4,8,12-trimethyl-3,7,11-tridecatrienyl]- (9CI)
- CAS:
- 65941-19-7
- MF:
- C31H40O2
- Structure:
- Chemical Name:
- Amifostine Impurity 15
- CAS:
- 10297-31-1
- MF:
- C7H17Br3N2
- Chemical Name:
- Doxylamine Impurity G
- Structure:
- Chemical Name:
- Pyrimidine, 4,6-dichloro-5-nitroso-2-(propylthio)-
- CAS:
- 2512210-19-2
- MF:
- C7H7Cl2N3OS
- Structure:
- Chemical Name:
- 5-Pyrimidinamine, 4,6-dichloro-N-hydroxy-2-(propylthio)-
- CAS:
- 2517939-84-1
- MF:
- C7H9Cl2N3OS
- Structure:
- Chemical Name:
- (R)-4-(4-methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl)benzenediazonium tetrafluoroborate
- CAS:
- 1630761-21-5
- MF:
- C11H11N4O+
- Chemical Name:
- 8-chloro-11-(1-((5-methylpyridin-3-yl)methyl)piperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine 1-oxide
- Chemical Name:
- N-acetyl-β-D-glucosidase
- Chemical Name:
- Bumetanide Impurity 23
- Chemical Name:
- Rocuronium Bromide Impurity 34、35、36
- Structure:
- Chemical Name:
- Vinpocetine impurity C
- CAS:
- 70155-05-4
- MF:
- C23H28N2O3
- Chemical Name:
- Cloxacillin Impurity X
- Structure:
- Chemical Name:
- Benzamide, 4-[7-[6-cyano-5-(trifluoromethyl)-3-pyridinyl]-6,8-dithioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methyl-
- CAS:
- 2649802-40-2
- MF:
- C21H15F4N5OS2
- Structure:
- Chemical Name:
- Benzamide, 4-[7-[6-cyano-5-(trifluoromethyl)-3-pyridinyl]-6,8-dithioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methyl-
- CAS:
- 2649802-40-2
- MF:
- C21H15F4N5OS2
- Chemical Name:
- 1-(4-((2-(4-hydroxypiperidin-1-yl)ethyl)(methyl)carbamoyl)benzyl)piperidine-4-carboxamide
- Structure:
- Chemical Name:
- ethyl (R)-thiazolidine-4-carboxylate
- CAS:
- 60664-15-5
- MF:
- C6H11NO2S
- Chemical Name:
- Oxytocin oxide impurity reference substance
- Chemical Name:
- Troxipide Impurity 7
- Chemical Name:
- Avatrombopag Impurity 44
- Chemical Name:
- Bendamustine Impurity 37A
- Chemical Name:
- Brivaracetam Impurity 50
- Chemical Name:
- 6-Hydroxymoxifloxacin Impurities
- Chemical Name:
- (S)-4-(((R)-1-carboxy-2-((3-hydroxypropyl)thio)ethyl)amino)-3-hydroxy-4-oxobutanoic acid
- Structure:
- Chemical Name:
- 1,3-bis(5-bromo-2-methoxyphenyl)adamantane
- CAS:
- 932033-56-2
- MF:
- C24H26Br2O2
- Structure:
- Chemical Name:
- (S)-dimethyl 2-(4-(((2,4-diaminopteridin-6-yl)methyl)(methyl)amino)benzamido)pentanedioate
- CAS:
- 67676-60-2
- MF:
- C22H27ClN8O5
- Structure:
- Chemical Name:
- 1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-3-(1-ethylpropoxy)-5-[[[5-(hydroxymethyl)-2-furanyl]methylene]amino]-, ethyl ester, (3S,4R,5S)-
- CAS:
- 2413185-90-5
- MF:
- C22H32N2O6
- Structure:
- Chemical Name:
- 2-Pyrazinecarboxylic acid, 6-methyl-, 4-oxide
- CAS:
- 51037-31-1
- MF:
- C6H6N2O3
- Chemical Name:
- NA
- Structure:
- Chemical Name:
- INDEX NAME NOT YET ASSIGNED
- CAS:
- 2681355-40-6
- MF:
- C29H34Cl2N6O4S2
- Chemical Name:
- Isavuconazole Impurity 48
- Chemical Name:
- 5,5'-((1R,1'R)-((5,6-diethyl-2,3-dihydro-1H-inden-2-yl)azanediyl)bis(1-hydroxyethane-2,1-diyl))bis(8-hydroxyquinolin-2(1H)-one)
- Structure:
- Chemical Name:
- (S)-2-(1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)-5-nitroisoindoline-1,3-dione
- MF:
- C20H20N2O8S
- Structure:
- Chemical Name:
- 2-(4-(2-(4-(1-(2-methoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropanoic acid
- MF:
- C27H35N3O3
- Chemical Name:
- Tafluprost Impurity 19
- Chemical Name:
- Rosuvastatin Impurity 162
- Chemical Name:
- Rosuvastatin Impurity 151
- Chemical Name:
- Rosuvastatin Impurity 148
- Structure:
- Chemical Name:
- FUROSEMIDE ACYL-B-D-GLUCURONIDE
- CAS:
- 72967-59-0
- MF:
- C18H19ClN2O11S
- Chemical Name:
- Digoxin Impurity 1
- Chemical Name:
- Azilsartan Impurity 107
- Chemical Name:
- Perospirone Impurity 25
- Chemical Name:
- Paxlovid Impurity 16
- Chemical Name:
- 3-(2-(cyclopent-1-en-1-yl)-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-ium bromide
- Chemical Name:
- Fondaparinux sodium impurity 17
- Chemical Name:
- Fondaparinux sodium impurity 12
- Chemical Name:
- Piperacillin impurity L
- Chemical Name:
- Piperacillin Impurity X
- Structure:
- Chemical Name:
- ETHYLTRITYLETHER
- CAS:
- 968-39-8
- MF:
- C21H20O
- Chemical Name:
- Bosutinib Impurity 41
- Structure:
- Chemical Name:
- (S)-3-Dimethylamino-3-phenylpropanol
- CAS:
- 82769-75-3
- MF:
- C11H17NO
- Structure:
- Chemical Name:
- N-(2-HYDROXYETHYL)ISONICOTINAMIDE, 99
- CAS:
- 6265-74-3
- MF:
- C8H10N2O2
- Structure:
- Chemical Name:
- BENAZEPRIL RELATED COMPOUND G (15 MG) ((3-(1 -ETHOXYCARBONYL-3-PHENYL-(1 S)-PROPYL)AMINO-2,3,4,5-TETRAHYDRO-2-OXO-1H-1-(3S)-BENZAZE-PINE)-1-ACETIC ACID, ETHYL ESTER)
- CAS:
- 103129-58-4
- MF:
- C26H32N2O5
- Structure:
- Chemical Name:
- CLOPIDOGREL RELATED COMPOUND C (20 MG) (METHYL (-)-(R)-(O-CHLOROPHENYL)-6,7-DIHYDROTHIE-NO[3,2-C]PYRIDINE-5(4H)-ACETATE, HYDROGEN SUL- FATE)
- CAS:
- 120202-71-3
- MF:
- C16H18ClNO6S2
- Structure:
- Chemical Name:
- 2-(3-(4-(7H-Pyrrolo[2,3-d]pyrimidin-2-yl)-1H-pyrazol-1-yl)-1-(ethylsulfonyl)azetidin-3-yl)acetonitrile
- MF:
- C16H17N7O2S
- Chemical Name:
- 6-BENZYLAMINOPURINE 9-(§-D-GLUCOSIDE)
- Chemical Name:
- Ipragliflozin Impurity 4
- Structure:
- Chemical Name:
- Mupirocin iMpurity 6
- MF:
- C26H44O9
- Structure:
- Chemical Name:
- Vitamin B1 Impurity 5
- CAS:
- 2443-50-7
- MF:
- C12H17ClN4OS
- Structure:
- Chemical Name:
- Irbesartan IMpurity 16
- MF:
- C25H28N6O
- Structure:
- Chemical Name:
- 479348-49-7
- CAS:
- 479348-49-7
- MF:
- C20H19FN2O6
- Structure:
- Chemical Name:
- 1449029-77-9
- CAS:
- 1449029-77-9
- MF:
- C29H26N4O7
- Structure:
- Chemical Name:
- 295366-48-2
- CAS:
- 295366-48-2
- MF:
- C17H25NO3
- Structure:
- Chemical Name:
- (3S,4R)-phenyl 3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-phenyl piperidine-1-carboxylate
- MF:
- C26H25NO5
- Structure:
- Chemical Name:
- Fluticasone Impurity 13
- MF:
- C25H31F3O5S
- Chemical Name:
- nicergoline impurity K
- Structure:
- Chemical Name:
- Clopidogrel Impurity 46
- CAS:
- 1801260-21-8
- MF:
- C25H26ClNO6S
- Structure:
- Chemical Name:
- Rosuvastatin Impurity 89
- CAS:
- 2226413-61-0
- MF:
- C38H46F2N6O9S2
- Structure:
- Chemical Name:
- Ibuprofen EP Impurity I
- CAS:
- 2143535-26-4
- MF:
- C13H18O2
- Chemical Name:
- Moxifloxacin Impurity 11
- Structure:
- Chemical Name:
- Linagliptin Impurity 7
- CAS:
- 2416949-69-2
- MF:
- C25H29N7O4
- Structure:
- Chemical Name:
- Tofacitinib Related Compound 16
- CAS:
- 2183519-70-0
- MF:
- C15H23N5
- Chemical Name:
- Afatinib Impurity OLQ
- Structure:
- Chemical Name:
- Androstane-3,17-diol,2-(4-morpholinyl)-16-(1-pyrrolidinyl)
- CAS:
- 119302-22-6
- MF:
- C31H50N2O5
- Chemical Name:
- Landiolol impurity W
- Structure:
- Chemical Name:
- Metoprolol IMpurity T
- MF:
- C15H25NO3
- Structure:
- Chemical Name:
- Teneligliptin Impurity 11
- CAS:
- 2131105-24-1
- MF:
- C25H35N5O4
- Chemical Name:
- Teneligliptin Impurity 16
- Structure:
- Chemical Name:
- IMP-EP-M
- CAS:
- 1193104-80-1
- MF:
- C60H79N2O15S+
- Chemical Name:
- Hyoscine Butylbromide EP Impurity H
- Structure:
- Chemical Name:
- 2-((4S,6S)-6-(2-aminoethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetic acid
- CAS:
- 2165770-84-1
- MF:
- C10H19NO4
- Structure:
- Chemical Name:
- Androstane-2,17-diol, 3-(4-morpholinyl)-16-(1-pyrrolidinyl)-, (2α,3β,5α,16β,17β)-
- CAS:
- 1252016-49-1
- MF:
- C27H46N2O3
- Structure:
- Chemical Name:
- (S)-N,N-dimethyl-3-((R)-3-(naphthalen-1-yloxy)-1-phenylpropoxy)-1-phenylpropan-1-amine
- MF:
- C30H33NO2
- Structure:
- Chemical Name:
- Crisaborole Impurity 16
- CAS:
- 2268785-42-6
- MF:
- C14H10BNO3
- Structure:
- Chemical Name:
- guanidine
- CAS:
- 113-00-8
- MF:
- CH5N3
- Structure:
- Chemical Name:
- tert-Butyl (E)-3,5-Dihydroxy-7-[3'-(4"-fluorophenyl)-1'-methylethylindol-2'-yl)hept-6-enoate
- CAS:
- 194934-96-8
- MF:
- C28H34FNO4
- Structure:
- Chemical Name:
- 3-((3R,4R)-3-(7H-[4,7'-bipyrrolo[2,3-d]pyrimidin]-4'-yl(methyl) amino)-4-methylpiperidin-1-yl)-3-oxopropanenitrile
- CAS:
- 2504210-48-2
- MF:
- C22H23N9O
- Chemical Name:
- Faropenem Impurity D
- Structure:
- Chemical Name:
- [2S-(2alpha,5alpha,6alpha)]-6-bromo-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
- CAS:
- 24138-28-1
- MF:
- C8H10BrNO3S
- Structure:
- Chemical Name:
- 5-nitro-2-furaldehyde (5-nitrofurfurylene)hydrazone
- CAS:
- 736-53-8
- MF:
- C10H6N4O6
- Structure:
- Chemical Name:
- 4-(benzo[b]thiophen-4-yl)-1,1-bis(4-((2-oxo-1,2-dihydroquinolin-7-yl)oxy)butyl)piperazin-1-ium chloride
- CAS:
- 2454317-16-7
- MF:
- C38H41N4O4S
- Structure:
- Chemical Name:
- methyl (R)-thiazolidine-4-carboxylate
- CAS:
- 42258-90-2
- MF:
- C5H9NO2S
- Structure:
- Chemical Name:
- Revefenacin Impurity 7
- CAS:
- 1158777-54-8
- MF:
- C14H19ClN2O3
- Chemical Name:
- Bimatoprost Impurity 23
- Chemical Name:
- Oxacillin Impurity IMPA
- Chemical Name:
- Rebamipide Impurity X(Rebamipide Impurity 7)