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:
- (S)-Phenylephrine hydrochloride
- CAS:
- 939-38-8
- MF:
- C9H14ClNO2
- Structure:
- Chemical Name:
- Acetamide, N-(4-hydroxyphenyl)-N-nitroso-
- CAS:
- 146897-60-1
- MF:
- C8H8N2O3
- Chemical Name:
- (5-(2-fluorophenyl)-1H-pyrrol-3-yl)methanamine hydrochloride
- Chemical Name:
- Rocuronium Bromide Impurity 24 、25
- Chemical Name:
- Bisoprolol Impurity 47
- Chemical Name:
- Gadobutrol Impurity 11(Ammonium salt)
- Chemical Name:
- Flomoxef Impurity F
- Chemical Name:
- Tegoprazan Impurity 15
- Chemical Name:
- Nirmatrelvir Impurity 8
- Chemical Name:
- Nirmatrelvir Impurity 2
- Chemical Name:
- Roxadustat Impurity 17
- Chemical Name:
- Perospirone Impurity 20
- CAS:
- 1002359-81-0
- Chemical Name:
- Dolutegravir Impurity 19
- Chemical Name:
- Cephalexin Impurity I
- Chemical Name:
- Fondaparinux sodium impurity 6
- Chemical Name:
- Fondaparinux sodium impurity 2
- Chemical Name:
- Oxacillin sodium Impurity I
- Chemical Name:
- Mixture of Cefoxitin Impurity E&F
- Chemical Name:
- Cefradine Impurity L
- Structure:
- Chemical Name:
- (8beta)-10methoxy-6-dimethylergoline-8-methanol-5-bromo-3-pyridinecarboxylate(ester)
- CAS:
- 35264-46-1
- MF:
- C23H24BrN3O3
- Chemical Name:
- Cephalexin Open-Ring Impurity
- Chemical Name:
- Urapidil Impurity 18
- Chemical Name:
- Flomoxef Impurity IV
- Chemical Name:
- Pitavastatin Impurity 54 Complete Set
- Chemical Name:
- Cetrorelix Impurity 15
- Chemical Name:
- Brivaracetam Impurity 46
- Chemical Name:
- Atracurium Impurity H Complete Set
- Chemical Name:
- Peramivir Intermediate Impurity 38
- Chemical Name:
- Ticagrelor impurity P drops
- Chemical Name:
- Pemetrexed Disodium Impurity 31-40
- Chemical Name:
- Paclitaxel EP impurity drops
- Chemical Name:
- Ticagrelor impurity PDD
- Chemical Name:
- Bimatoprost Impurity S
- Chemical Name:
- Oxacillin sodium EP impurity J
- Chemical Name:
- Piperacillin Sodium EP Impurity P
- Chemical Name:
- (S)-N-(4-((3-chloro-4-fluorophenyl)amino)-7-((tetrahydrofuran-3-yl)oxy)quinazolin-6-yl)-4-(dimethylamino)butanamide
- Chemical Name:
- Ertapenem Impurity B(USP)
- Structure:
- Chemical Name:
- INDEX NAME NOT YET ASSIGNED
- CAS:
- 2458312-06-4
- MF:
- C27H30N2O6
- Structure:
- Chemical Name:
- 15(R)-17-PHENYL TRINOR PROSTAGLANDIN F2ALPHA
- CAS:
- 41639-71-8
- MF:
- C23H32O5
- Chemical Name:
- (5R,6S)-6-((R)-1-hydroxyethyl)-3-((R)-tetrahydrofuran-2-yl)-4-thia-1-azabicyclo[3.2.0]hept-2-en-7-one
- Chemical Name:
- RICE BRAN OIL
- CAS:
- 68553-81-1
- Structure:
- Chemical Name:
- 3-Azetidineacetonitrile, 1-(ethylsulfonyl)-3-[4-(1H-pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidin-7-yl]-
- CAS:
- 2402776-83-2
- MF:
- C16H17N7O2S
- Chemical Name:
- Iohexol ImpuritiesE
- Structure:
- Chemical Name:
- TERT-BUTYL (R)-6-CHLORO-5-HYDROXY-3-OXOHEXANOATE
- CAS:
- 404958-08-3
- MF:
- C10H17ClO4
- Chemical Name:
- 8-chloro-11-(1-((5-methylpyridin-3-yl)methyl)piperidin-4-yl)-11H-benzo[5,6]cyclohepta[1,2-b]pyridine
- Chemical Name:
- Bumetanide Photodegradable Impurity 16
- Chemical Name:
- Revefenacin Impurity 22
- Chemical Name:
- Lasmiditan Impurity 7
- Chemical Name:
- Febuxostat impurity BAC
- Structure:
- Chemical Name:
- 4-(3,4-DICHLOROPHENYL)-1,2,3,4-TETRAHYDRO-1-NAPHTHALENOL
- CAS:
- 866018-46-4
- MF:
- C16H14Cl2O
- 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:
- (2R,3S)-3-amino-2-((Z)-2-(2-aminothiazol-4-yl)-2-(((2-carboxypropan-2-yl)oxy)imino)acetamido)butanoic acid
- 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:
- 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
- Chemical Name:
- Peramivir Impurity 57
- Structure:
- Chemical Name:
- 2-Thiazolamine, 4-(5-bromo-4-chloro-2-thienyl)-
- CAS:
- 1534575-19-3
- MF:
- C7H4BrClN2S2
- Chemical Name:
- NA
- Chemical Name:
- BrivaracetamImpurity ABCDEFGHJKL
- Chemical Name:
- Bimatoprost Impurity 17
- Chemical Name:
- Bumetanide Impurity 10
- Chemical Name:
- Cefoxitin EP Impurity E (R-methoxy cefoxitin)
- Structure:
- Chemical Name:
- 4(1H)-Pyrimidinone, 5-amino-6-chloro-2-(propylthio)-
- CAS:
- 2512210-21-6
- MF:
- C7H10ClN3OS
- Structure:
- Chemical Name:
- Carbamic acid, N-[(1S)-1-methyl-2-oxo-2-[3-(phenylmethoxy)phenyl]ethyl]-, phenylmethyl ester
- CAS:
- 2151127-61-4
- MF:
- C24H23NO4
- Structure:
- Chemical Name:
- 1-(chloromethyl)-4-(dichloromethyl)benzene
- CAS:
- 7398-44-9
- MF:
- C8H7Cl3
- Structure:
- Chemical Name:
- 4,4'-(propane-1,3-diyl)bismorpholine
- CAS:
- 48152-09-6
- MF:
- C11H22N2O2
- Structure:
- Chemical Name:
- BIS(2,6-DIPHENYLPHENOXY)NIOBIUM(V) CHLOR
- CAS:
- 699012-35-6
- MF:
- C42H32Cl3NbO2
- Chemical Name:
- Brivaracetam Impurity 62
- Chemical Name:
- Lumateperone Impurity 4
- Chemical Name:
- SugammadexImpurity021
- Chemical Name:
- Pabocillin Impurity 28
- Chemical Name:
- Cefmetazole Sodium Impurity C
- Chemical Name:
- Ceftriaxone Sodium Oxide Impurity
- Chemical Name:
- 2-[4-(Azidomethyl)phenyl]benzamide
- Structure:
- Chemical Name:
- 1H-Benzimidazole-7-carboxylic acid, 1-[[2'-[4,5-dihydro-4-[(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl]-5-oxo-1,2,4-oxadiazol-3-yl][1,1'-biphenyl]-4-yl]methyl]-2-ethoxy-
- CAS:
- 1985638-55-8
- MF:
- C30H24N4O8
- Structure:
- Chemical Name:
- 2H-1,4-Benzoxazin-3(4H)-one, 8-[(1R)-2-bromo-1-hydroxyethyl]-6-(phenylmethoxy)-
- CAS:
- 2248125-51-9
- MF:
- C17H16BrNO4
- Structure:
- Chemical Name:
- Morpholine, 4-[4-(1,1-dimethylethoxy)-1,2,5-thiadiazol-3-yl]-
- CAS:
- 158636-99-8
- MF:
- C10H17N3O2S
- Chemical Name:
- Pemetrexed disodium Impurity 30
- Chemical Name:
- Ruxolitinib ImpurityABCDEFGHJKL
- Chemical Name:
- Avatrombopag Impurity 76
- Chemical Name:
- Rosuvastatin Impurity 153
- Chemical Name:
- Rosuvastatin Impurity 138
- Chemical Name:
- Rosuvastatin Impurity 127