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-Azabicyclo[3.1.0]hexane-2-carboxamide, N-[(1R)-1-cyano-2-[(3S)-2-oxo-3-pyrrolidinyl]ethyl]-3-[(2S)-3,3-dimethyl-1-oxo-2-[(2,2,2-trifluoroacetyl)amino]butyl]-6,6-dimethyl-, (1R,2S,5S)-
- CAS:
- 2755812-41-8
- MF:
- C23H32F3N5O4
- Chemical Name:
- 3-(4-cyanophenoxy)benzyl acetate
- CAS:
- 2990481-66-6
- Chemical Name:
- Bisoprolol Impurity 53
- Chemical Name:
- Abiolone Impurity 24
- Chemical Name:
- Deerasirox Impurity II
- Chemical Name:
- Brivaracetam Impurity 49
- Chemical Name:
- Paroxetine EP Impurity J HCl
- Chemical Name:
- Brivaracetam Impurity 99
- Chemical Name:
- Bendamustine Impurity 39
- Chemical Name:
- AvatrombopagImpurity42
- Chemical Name:
- (R)-4-(((R)-1-carboxy-2-((3-hydroxypropyl)thio)ethyl)amino)-3-hydroxy-4-oxobutanoic acid
- Structure:
- Chemical Name:
- Hydrazinecarboxamide, 2-(6-hydroxy-1-methyl-1H-indol-5-yl)-
- CAS:
- 70063-07-9
- MF:
- C10H12N4O2
- Structure:
- Chemical Name:
- 1H-Pyrrole-3-carboxaldehyde, 1-[(5-chloro-3-pyridinyl)sulfonyl]-5-(2-fluorophenyl)-
- CAS:
- 2514742-82-4
- MF:
- C16H10ClFN2O3S
- Chemical Name:
- Crisaborole Impurity 20
- Chemical Name:
- (Z)-N-(4-((3-chloro-4-fluorophenyl)amino)-7-methoxyquinazolin-6-yl)-4-(piperidin-1-yl)but-2-enamide
- Chemical Name:
- (1S,3R,5S,6R)-6-hydroxy-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 2-hydroxy-2,2-di(thiophen-2-yl)acetate
- Chemical Name:
- Nicergoline EP Impurity IJ
- Chemical Name:
- Fulvestrant impurityABCDEFGHJKL
- Structure:
- Chemical Name:
- 2-((6S,8S,9S,10S,11S,13S,14S,17R)-11,17-dihydroxy-6,10,13-trimethyl-3-oxohexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl acetate
- CAS:
- 114696-04-7
- MF:
- C24H36O6
- Chemical Name:
- Isavuconazole Impurity 49
- Chemical Name:
- (R)-5-(2-((5,6-diethyl-2,3-dihydro-1H-inden-2-yl)amino)-1-methoxyethyl)-8-hydroxyquinolin-2(1H)-one
- Chemical Name:
- Avatrombopag Impurity 51
- Chemical Name:
- Tafluprost Impurity 18
- Chemical Name:
- Rosuvastatin Impurity 161
- Chemical Name:
- Rosuvastatin Impurity 155
- Chemical Name:
- Rosuvastatin Impurity 146
- Chemical Name:
- Rosuvastatin Impurity 126
- Structure:
- Chemical Name:
- (1R,3r,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 2-hydroxy-2,2-di(thiophen -2-yl)acetate
- CAS:
- 29461-90-3
- MF:
- C18H21NO3S2
- Chemical Name:
- Digoxin Impurity 2
- Structure:
- Chemical Name:
- DUTP, 100MM SOLUTION
- CAS:
- 94736-09-1
- MF:
- C9H16N2NaO14P3
- Chemical Name:
- Oxacillin USP Impurity D
- Chemical Name:
- Oxacillin sodium EP impurity B
- Chemical Name:
- Methylprednisolone EP Impurity D1
- Chemical Name:
- Nirmatrelvir Impurity 13
- Structure:
- Chemical Name:
- 2-Pyridinecarboxamide, 4-hydroxy-N-methyl- (9CI)
- CAS:
- 611226-36-9
- MF:
- C7H8N2O2
- Structure:
- Chemical Name:
- 2-Pyridinemethanol, 4-hydroxy-3,5-dimethyl- (9CI)
- CAS:
- 727375-13-5
- MF:
- C8H11NO2
- Chemical Name:
- Bumetanide Impurity 22
- Chemical Name:
- Rocuronium Bromide Impurity 32 、33
- Chemical Name:
- Flucloxacillin Sodium Impurity X
- Chemical Name:
- Pitavastatin Impurity 98
- Chemical Name:
- Perospirone Impurity 29
- Chemical Name:
- Perospirone Impurity 24
- Chemical Name:
- Perospirone Impurity 7
- CAS:
- 1002359-81-0
- Chemical Name:
- 2-methyl-4-(((2E,6E,10E)-3,7,11,15-tetramethylhexadeca-2,6,10,14- tetraen-1-yl)oxy)naphthalen-1-yl acetate
- Chemical Name:
- Paxlovid Impurity 17
- Chemical Name:
- Related impurities of fluoxetine sodium 19
- Chemical Name:
- Fondaparinux sodium impurity 16
- Chemical Name:
- Fondaparinux Sodium Impurity 11
- Chemical Name:
- Oxacillin Impurity E
- Structure:
- Chemical Name:
- AZOBENZENE-3-CARBOXYLICACID
- CAS:
- 14474-22-7
- MF:
- C13H10N2O2
- Chemical Name:
- Bosutinib Impurity 40
- Chemical Name:
- Ticagrelor Impurity J&K
- Structure:
- Chemical Name:
- 2-PENTANOYLBENZOIC ACID
- CAS:
- 550-37-8
- MF:
- C12H14O3
- Structure:
- Chemical Name:
- Chloromethyl ethyl carbonate
- CAS:
- 35179-98-7
- MF:
- C4H7ClO3
- Chemical Name:
- Bimatoprost Impurity 10
- Chemical Name:
- Carbetocin S-Oxide II
- Structure:
- Chemical Name:
- Empagliflozin Impurity 82
- CAS:
- 2452301-16-3
- MF:
- C17H16ClIO2
- Chemical Name:
- Empagliflozin Impurity 88
- Structure:
- Chemical Name:
- Tofacitinib Impurity K
- CAS:
- 2328165-36-0
- MF:
- C16H21N5O3
- Structure:
- Chemical Name:
- Olopatadine Impurity 13
- CAS:
- 55453-90-2
- MF:
- C18H16O4
- Chemical Name:
- Avibactam sodium Impurity CIA
- Structure:
- Chemical Name:
- 4-((2-amino-2-oxoethyl)amino)butanoic acid
- CAS:
- 1096803-44-9
- MF:
- C6H12N2O3
- Structure:
- Chemical Name:
- Lenvatinib impurity LFZZ-17
- MF:
- C11H9NO4
- Chemical Name:
- Ornidazole Impurity 25
- Chemical Name:
- Pitavastatin Impurity 72
- Chemical Name:
- Febuxostat Impurity 109
- Chemical Name:
- Brivaracetam Impurity 37
- Chemical Name:
- Ticagrelor Impurity 133
- Structure:
- Chemical Name:
- 3-(Dimethylamino)-1-(2-thienyl)-1-propanol
- CAS:
- 13636-02-7
- MF:
- C9H15NOS
- Structure:
- Chemical Name:
- Benzamide, 2,5-dichloro-N-(3-methylbutyl)-
- CAS:
- 349086-08-4
- MF:
- C12H15Cl2NO
- Structure:
- Chemical Name:
- BECLOTIAMINE
- CAS:
- 13471-78-8
- MF:
- C12H16Cl2N4S
- Structure:
- Chemical Name:
- methyl 5-sulpho-o-anisate
- CAS:
- 94134-07-3
- MF:
- C9H10O6S
- Structure:
- Chemical Name:
- 2,4-dioxo-3-azaspiro[5.5]undecane-1,5-dicarbonitrile
- CAS:
- 4355-15-1
- MF:
- C12H13N3O2
- Structure:
- Chemical Name:
- INDEX NAME NOT YET ASSIGNED
- CAS:
- 2412953-11-6
- MF:
- C72H112O49S8
- Structure:
- Chemical Name:
- Sulfamide, N-[5-phenyl-6-[2-(2-pyrimidinyloxy)ethoxy]-4-pyrimidinyl]-N'-propyl-
- CAS:
- 2300968-85-6
- MF:
- C19H22N6O4S
- Structure:
- Chemical Name:
- Acetamide, 2-chloro-N-(2-chloroacetyl)-N-(2,6-dimethylphenyl)-
- CAS:
- 112843-97-7
- MF:
- C12H13Cl2NO2
- Structure:
- Chemical Name:
- 2-chloro-N-(2,4-dimethylphenyl)acetamide
- CAS:
- 39106-10-0
- MF:
- C10H12ClNO
- Structure:
- Chemical Name:
- sodium [2S-(2alpha,5alpha,6beta)]-6-bromo-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
- CAS:
- 73335-78-1
- MF:
- C8H9BrNNaO3S
- Structure:
- Chemical Name:
- 8-chloro-3,7-dihydro-1,3,7-trimethyl-1H-purine-2,6-dione
- CAS:
- 4921-49-7
- MF:
- C8H9ClN4O2
- Structure:
- Chemical Name:
- (R)-8-(3-aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-2-((4-methylquinazolin-2-yl)methoxy)-3,7-dihydro-6H-purin-6-one
- CAS:
- 2446799-72-8
- MF:
- C25H28N8O2
- Chemical Name:
- CETEARYL GLUCOSIDE
- Chemical Name:
- Troxipide Impurity 8
- Chemical Name:
- Peramivir Impurity 12/11
- Chemical Name:
- (1S,2R,3R,4R)-3-((S)-1-acetamido-2-ethylbutyl)-4-guanidino-2-hydroxycyclopentane-1-carboxylic acid
- Chemical Name:
- Ceftazidime Impurity IMPA
- Chemical Name:
- Pitavastatin Impurity 82
- Chemical Name:
- Meropenem Impurity MAP-B
- Chemical Name:
- (S,E)-N-(4-((3-chloro-4-fluorophenyl)amino)-7-((tetrahydrofuran-3-yl)oxy)quinazolin-6-yl)-4-hydroxybut-2-enamide
- Chemical Name:
- Doxylamine Impurity E
- Structure:
- Chemical Name:
- Phenoxymethylpenicillin Potassium EP Impurity F
- CAS:
- 2714805-53-3
- MF:
- C15H20N2O4S
- Chemical Name:
- Olodaterol Impurity 24
- Chemical Name:
- Miglitol Isomer ImpurityB
- Chemical Name:
- 43,50-Dicarboxy-cyanoco balamin
- Structure:
- Chemical Name:
- (1R,4S) Sertraline Hydrochloride
- CAS:
- 79896-32-5
- MF:
- C17H18Cl3N
- Structure:
- Chemical Name:
- 4-Desmethoxy-4-chloro Omeprazole Sulfide
- CAS:
- 220757-74-4
- MF:
- C16H16ClN3OS
- Structure:
- Chemical Name:
- N-Desmethyl Tamoxifen Hydrochloride
- CAS:
- 15917-65-4
- MF:
- C25H27NO.ClH
- Structure:
- Chemical Name:
- (3S,5S)-Atorvastatin sodium salt
- CAS:
- 501121-34-2
- MF:
- C33H35FN2O5