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:Pitavastatin Impurity 13
- CAS:
- MF:
- Chemical Name:Pramipexole Impurity R
- CAS:
- MF:
- Chemical Name:Tadalafil Impuirty 21
- CAS:
- MF:
- Structure:
- Chemical Name:3-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]-2-[1-[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]pentan-2-yl]-1,3-diazaspiro[4.4]non-1-en-4-one
- CAS:1346598-52-4
- MF:C39H38N10O
- Structure:
- Chemical Name:1,11-ditosyl-1,4,8,11-tetraazacyclotetradecane dihydrochloride
- CAS:117152-73-5
- MF:C24H36N4O4S2
- Structure:
- Chemical Name:PeraMpanel
- CAS:684648-40-6
- MF:C10H10BNO2
- Structure:
- Chemical Name:3-CHLORO-N-(3-METHOXYPHENYL)PROPANAMIDE
- CAS:21261-76-7
- MF:C10H12ClNO2
- Structure:
- Chemical Name:Amlodipine Impurity 31
- CAS:496024-43-2
- MF:C20H22ClNO5
- Chemical Name:Fudosteine Impurity 5
- CAS:
- MF:
- Structure:
- Chemical Name:Rasagiline Impurity 4
- CAS:1175018-79-7
- MF:C12H14ClN
- Structure:
- Chemical Name:CAPECITABINE-D11
- CAS:1132662-08-8
- MF:C15H13D11FN3O6
- Chemical Name:Piperacillin Impurity N
- CAS:
- MF:
- Structure:
- Chemical Name:2-(1-(dimethylamino)ethyl)phenol 2,3-dihydroxysuccinate
- CAS:26050-44-2
- MF:C10H15NO
- Structure:
- Chemical Name:Miconazole EP Impurity F
- CAS:47447-55-2
- MF:C18H14Cl4N2O
- Structure:
- Chemical Name:Raltegravir USP RC E
- CAS:1193687-87-4
- MF:C20H22N6O5
- Structure:
- Chemical Name:Vigabatrin EP Impurity F
- CAS:794466-81-2
- MF:C12H20N2O3
- Structure:
- Chemical Name:Dehydronitrosonisoldipine
- CAS:87375-91-5
- MF:C20H22N2O5
- Structure:
- Chemical Name:Brexpiprazole Impurity 49
- CAS:1700655-67-9
- MF:C13H14N2O2S
- Structure:
- Chemical Name:Etoricoxib Impurity 38
- CAS:887479-63-2
- MF:C13H17NO2S
- Structure:
- Chemical Name:Pemetrexed Impurity 19
- CAS:1644286-36-1
- MF:C20H21N5O8
- Chemical Name:Empagliflozin Impurity 31
- CAS:
- MF:
- Structure:
- Chemical Name:Iguratimod
- CAS:123663-50-3
- MF:C18H16N2O6S
- Structure:
- Chemical Name:Imidafenacin Related Compound 10
- CAS:212756-27-9
- MF:C21H23N3O
- Structure:
- Chemical Name:Aprepitant
- CAS:1242175-36-5
- MF:C20H18F7NO2
- Structure:
- Chemical Name:Idebenone Impurity 5
- CAS:88543-33-3
- MF:C18H28O5
- Structure:
- Chemical Name:Entacapone Impurity 4
- CAS:1202160-40-4
- MF:C11H8N2O6
- Structure:
- Chemical Name:L-Leucine, N-formyl-, (1S)-1-[[(2S,3S)-3-hexyl-4-oxo-2-oxetanyl]methyl]tridecyl ester
- CAS:1119226-56-0
- MF:C30H55NO5
- Structure:
- Chemical Name:Itraconazole Impurity 17
- CAS:854372-78-4
- MF:C14H15Cl2N3O5S
- Structure:
- Chemical Name:sodium (41S,12R,13aS)-13a-ethyl-12-hydroxy-2,3,41,5,6,12, 13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5] naphthyridine-12-carboxylate
- CAS:53448-45-6
- MF:C20H24N2O3
- Structure:
- Chemical Name:Rivaroxaban Impurity 35
- CAS:2206360-74-7
- MF:C23H24N4O6
- Structure:
- Chemical Name:Tirofiban hydrochloride monohydrate Impurity 7
- CAS:2250244-28-9
- MF:C13H19NO5S
- Chemical Name:Acarbose Impurity G
- CAS:
- MF:
- Structure:
- Chemical Name:Imidafenacin Related Compound 7
- CAS:191592-57-1
- MF:C16H13N
- Structure:
- Chemical Name:17β-Cyanmethyl-oestra-1,3,5(10)-trien-3,17β-diol
- CAS:16669-06-0
- MF:C20H25NO2
- Chemical Name:Cefaclor Impurity 6
- CAS:
- MF:
- Structure:
- Chemical Name:Cephalexin Impurity 6
- CAS:
- MF:C16H17N3O4S
- Chemical Name:Pitavastatin Impurity 42
- CAS:
- MF:
- Structure:
- Chemical Name:Rocuronium bromide Impurity J
- CAS:
- MF:C32H53BrN2O4
- Chemical Name:Tofacitinib Impurity 72
- CAS:
- MF:
- Chemical Name:Tofacitinib Impurity 81
- CAS:
- MF:
- Structure:
- Chemical Name:Topiroxostat Impurity 9
- CAS:2044708-04-3
- MF:C7H10N6O
- Chemical Name:Vinorelbine EP Impurity C
- CAS:
- MF:
- Structure:
- Chemical Name:2-Benzylidene isobutyryl acetanilide
- CAS:125971-57-5
- MF:C19H19NO2
- Structure:
- Chemical Name:ISOPROPYLAMINE HYDROCHLORIDE
- CAS:15572-56-2
- MF:C3H10ClN
- Structure:
- Chemical Name:5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 3-[[(aminocarbonyl)oxy]methyl]-7-methoxy-7-[[(2S)-2-methoxy-2-(2-thienyl)acetyl]amino]-8-oxo-, (6R,7S)-
- CAS:2395025-37-1
- MF:C17H19N3O8S2
- Structure:
- Chemical Name:Atorvastatin Impurity 83
- CAS:1807481-00-0
- MF:C33H35F2N2NaO5
- Structure:
- Chemical Name:Loteprednol Etabonate Ethyl Ester (Prednisolone 20-Ethyl Ester)
- CAS:182069-19-8
- MF:C25H34O7
- Structure:
- Chemical Name:Hexanamide, N-[(1S)-1-(aminocarbonyl)propyl]-3-(hydroxymethyl)-, (3R)-
- CAS:2252417-17-5
- MF:C11H22N2O3
- Structure:
- Chemical Name:1H-Benzimidazole-6-carboxylic acid, 4-hydroxy-2-methyl-1-(phenylmethyl)-, ethyl ester
- CAS:1640981-16-3
- MF:C18H18N2O3
- Structure:
- Chemical Name:Benzoic acid, 2-chloro-4-nitro-, 2-(diethylamino)ethyl ester
- CAS:10367-96-1
- MF:C13H17ClN2O4
- Chemical Name:(2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl isopropyl sulfate
- CAS:
- MF:
- Structure:
- Chemical Name:Benzenepropanoic acid, 2,4-dichloro-α-[(dimethylamino)methylene]-3-methyl-β-oxo-, ethyl ester
- CAS:2241304-69-6
- MF:C15H17Cl2NO3
- Structure:
- Chemical Name:(S)-3-Methyl-1-(2-piperidin-1-ylphenyl)butylamine
- CAS:147769-93-5
- MF:C16H26N2
- Structure:
- Chemical Name:2-CHLORO-N-(2,3-DIMETHYL-PHENYL)-ACETAMIDE
- CAS:2564-07-0
- MF:C10H12ClNO
- Structure:
- Chemical Name:1,4-dihydro-2,6-dimethyl-4-(3'-nitrophenyl)-pyridine-3,5-dicarboxylic acid monoisopropyl ester
- CAS:116983-17-6
- MF:C18H20N2O6
- Chemical Name:Cabozantinib impurity 37
- CAS:
- MF:
- Chemical Name:4-(1-bromoethyl)-6-(1-(6-chloro-5-fluoropyrimidin-4-yl)ethyl)-5-fluoropyrimidine
- CAS:
- MF:
- Chemical Name:Dapoxetine impurity 53
- CAS:
- MF:
- Structure:
- Chemical Name:Apigenin 4'-O-(2'',6''-di-O-E-p-coumaroyl)glucoside
- CAS:71781-79-8
- MF:C39H32O14
- Chemical Name:Dapoxetine impurity 70
- CAS:
- MF:
- Structure:
- Chemical Name:Bosutinib Impurity 38
- CAS:2095306-26-4
- MF:C46H44Cl4N8O6
- Structure:
- Chemical Name:(2RS)-2-(4-ETHYLPHENYL)PROPANOIC ACID
- CAS:3585-52-2
- MF:C11H14O2
- Structure:
- Chemical Name:(E)-(3,4-Dihydro-7-methoxy-1(2H)-naphthalenylidene)acetonitrile
- CAS:178676-65-8
- MF:C13H13NO
- Structure:
- Chemical Name:3-[(2-[(E)-2-(3-ETHYL-1,3-BENZOTHIAZOL-3-IUM-2-YL)ETHENYL]-6-((E)-2-[3-ETHYL-1,3-BENZOTHIAZOL-2(3H)-YLIDENE]ETHYLIDENE)-4-METHYL-1-CYCLOHEXEN-1-YL)OXY]-1-PROPANESULFONATE
- CAS:
- MF:C32H36N2O4S3
- Chemical Name:Bimatoprost Impurity 15
- CAS:
- MF:
- Structure:
- Chemical Name:Bisoprolol Impurity 9
- CAS:59383-52-7
- MF:C15H25NO3
- Chemical Name:Empagliflozin Impurity 87
- CAS:
- MF:
- Chemical Name:Amoxicillin USP Impurity M
- CAS:
- MF:
- Structure:
- Chemical Name:Aztreonam Impurities 06
- CAS:730928-60-6
- MF:C26H34N10O16S4
- Structure:
- Chemical Name:Lenvatinib Impurity LFZZ-9
- CAS:
- MF:C43H38Cl2N8O8
- Chemical Name:Rosuvastatin Impurity 118
- CAS:
- MF:
- Chemical Name:Rosuvastatin Impurity 117
- CAS:
- MF:
- Structure:
- Chemical Name:Cytarabine Impurity 10
- CAS:84902-98-7
- MF:C4H6N2O3
- Chemical Name:Ticagrelor Impurity 108
- CAS:
- MF:
- Structure:
- Chemical Name:4-Piperidinecarboxylic acid, 1-[5-[[[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]amino]carbonyl]-3-hydroxy-2-pyridinyl]-
- CAS:1290121-42-4
- MF:C29H35ClN6O4S2
- Structure:
- Chemical Name:1,?4-?Piperazinediacetamid?e, N1,?N4-?dimethyl-?N1,?N4-?bis(4-?nitrophenyl)?-
- CAS:2410649-54-4
- MF:C22H26N6O6
- Structure:
- Chemical Name:1H-Pyrrole-3-methanamine, 1-[(1,6-dihydro-3-pyridinyl)sulfonyl]-5-(2-fluorophenyl)-N-methyl-
- CAS:2416241-95-5
- MF:C17H18FN3O2S
- Structure:
- Chemical Name:Dolutegravir Impurity 8
- CAS:2244161-72-4
- MF:C20H19F2N3O5
- Structure:
- Chemical Name:Benzonitrile, 4-[3-[(acetyloxy)methyl]-4-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)phenoxy]-
- CAS:2227126-13-6
- MF:C22H24BNO5
- Structure:
- Chemical Name:(Z)-2-[[[(2-Amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl] carbamoyl]methylene]amino]oxy]-2-methylpropionic acid methyl ester
- CAS:1255912-98-1
- MF:C14H19N5O8S2
- Structure:
- Chemical Name:Benzeneacetic acid, α-1-cyclopenten-1-yl-α-hydroxy-, (αR)-
- CAS:185030-09-5
- MF:C13H14O3
- Structure:
- Chemical Name:1-Piperazinecarboxaldehyde, 4-cyclohexyl-
- CAS:2325305-38-0
- MF:C11H20N2O
- Structure:
- Chemical Name:1H-Pyrrole-1-acetic acid, α-ethyl-2,5-dihydro-2-oxo-4-propyl-, (αS)-
- CAS:2170761-55-2
- MF:C11H17NO3
- Chemical Name:Revefenacin ImpurityABCDEFGHJKL
- CAS:
- MF:
- Chemical Name:Peramivir Impurity 57
- CAS:
- MF:
- Structure:
- Chemical Name:2-Thiazolamine, 4-(5-bromo-4-chloro-2-thienyl)-
- CAS:1534575-19-3
- MF:C7H4BrClN2S2
- Chemical Name:NA
- CAS:
- MF:
- Chemical Name:BrivaracetamImpurity ABCDEFGHJKL
- CAS:
- MF:
- Structure:
- Chemical Name:DEHYDRO FELODIPINE-13C4
- CAS:96382-71-7
- MF:C18H17Cl2NO4
- Chemical Name:Avatrombopag Impurity 24
- CAS:
- MF:
- Structure:
- Chemical Name:Cisatracurium besylate impurity 20
- CAS:96946-54-2
- MF:C59H77N2O15S+
- Structure:
- Chemical Name:N-Desmethylondansetron
- CAS:99614-14-9
- MF:C17H17N3O
- Structure:
- Chemical Name:CHEMPACIFIC 59929
- CAS:856240-62-5
- MF:C18H24O4
- Chemical Name:Linagliptin ImpurityABCDEF
- CAS:
- MF: