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:
- GINKGOLIC ACIDS
- Structure:
- Chemical Name:
- R-DULOXETINE HYDROCHLORIDE
- CAS:
- 910138-96-4
- MF:
- C18H20ClNOS
- Chemical Name:
- Rosuvastatin Impurity 172
- Structure:
- Chemical Name:
- pefloxacin N-oxide
- CAS:
- 85145-21-7
- MF:
- C17H20FN3O4
- Structure:
- Chemical Name:
- 2,3-dimethyl-1,4-naphthoquinone
- CAS:
- 2197-57-1
- MF:
- C12H10O2
- Structure:
- Chemical Name:
- L-Alanine,propylester(9CI)
- CAS:
- 58989-06-3
- MF:
- C6H13NO2
- Chemical Name:
- Oprinone Impurity 4
- Chemical Name:
- Mizolastine impurity C
- Structure:
- Chemical Name:
- N-hydroxyphenetidine
- CAS:
- 38246-95-6
- Structure:
- Chemical Name:
- bergaptol-O-glucopyranoside
- CAS:
- 131623-13-7
- MF:
- C17H16O9
- Structure:
- Chemical Name:
- (1-ETHYL-3-PIPERIDINYL)METHYLAMINE
- CAS:
- 102459-02-9
- MF:
- C8H18N2
- Structure:
- Chemical Name:
- 8-HYDROXY MIRTAZAPINE
- CAS:
- 102335-57-9
- MF:
- C17H19N3O
- Structure:
- Chemical Name:
- 1-[2-Amino-1-(4-benzyloxyphenyl)-ethyl]-cyclohexanol
- CAS:
- 93413-61-7
- MF:
- C23H31NO2
- Chemical Name:
- Perospirone Impurity 26
- Chemical Name:
- Paxlovid Impurity 15
- Chemical Name:
- 3-(2-(cyclopent-2-en-1-yl)-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-ium bromide
- Chemical Name:
- Canagliflozin Impurity 84
- Chemical Name:
- Fondaparinux sodium impurity 18
- Chemical Name:
- Oseltamivir Impurity 107
- Chemical Name:
- Oseltamivir Impurity 66
- Chemical Name:
- Peramivir dehydrated deacetylated impurity
- Chemical Name:
- Oseltamivir Impurity 120
- Chemical Name:
- Cilastatin Impurity H
- Structure:
- Chemical Name:
- 4-[5-({2-[(4-{5-[Bis(2-chloroethyl)amino]-1-methyl-1H-benzimidazol-2-yl}butanoyl)oxy]ethyl}(2-chloroethyl)amino)-1-methyl-1H benzimidazol-2-yl]butanoic acid
- CAS:
- 1926162-37-9
- MF:
- C32H42Cl4N6O4
- Structure:
- Chemical Name:
- Isavuconazole Impurity 39
- CAS:
- 207224-73-5
- MF:
- C21H18F2N4OS
- Chemical Name:
- Anastrozole Impurity 41
- Chemical Name:
- Isavuconazole Impurityi45
- Structure:
- Chemical Name:
- Gatifloxacinacid
- CAS:
- 121577-32-0
- MF:
- C19H22FN3O4.ClH
- Chemical Name:
- Bisoprolol Impurity 41
- Structure:
- Chemical Name:
- 1,4-Naphthalenedione, 2-(3-hydroxy-3,7,11,15-tetramethyl-1,6,10,14-hexadecatetraenyl)-3-methyl-, (,E,E)- (9CI)
- CAS:
- 65061-22-5
- MF:
- C31H40O3
- Chemical Name:
- Piperacilin
- Chemical Name:
- Varenicline Impurity D
- CAS:
- 1002359-81-0
- Structure:
- Chemical Name:
- 2-Propanone, 1-(2-hydroxypropoxy)- (9CI)
- CAS:
- 90817-38-2
- MF:
- C6H12O3
- Chemical Name:
- Nirmatrelvir Impurity 4
- Chemical Name:
- Nifedipine Impurity L
- Chemical Name:
- Fondaparinux sodium impurity 13
- Chemical Name:
- Lasmiditan Impurity 1
- Chemical Name:
- (5R,6R)-6-((R)-1-hydroxyethyl)-3-((R)-tetrahydrofuran-2-yl)-4-thia-1-azabicyclo[3.2.0]hept-2-en-7-one
- Chemical Name:
- Olodaterol Impurity 22
- Chemical Name:
- Olodaterol Impurity 25
- Chemical Name:
- Cationic panthenol
- Chemical Name:
- 32,43,50-Tricarboxy-cyanoco balamin
- Structure:
- Chemical Name:
- (S)-Azelastine
- CAS:
- 143228-85-7
- MF:
- C22H24ClN3O
- Chemical Name:
- Relugolix Impurity 92
- Structure:
- Chemical Name:
- N-Desethyl Vardenafil
- CAS:
- 448184-46-1
- MF:
- C21H28N6O4S
- Structure:
- Chemical Name:
- O-Desmethyl Gefitinib
- CAS:
- 847949-49-9
- MF:
- C21H22ClFN4O3
- Structure:
- Chemical Name:
- Pyrazole N-Demethyl Sildenafil
- CAS:
- 139755-95-6
- MF:
- C21H28N6O4S
- Structure:
- Chemical Name:
- S-(-)-Tolterodine
- CAS:
- 124937-53-7
- MF:
- C22H31NO
- Structure:
- Chemical Name:
- Zolmitriptan N-Oxide
- CAS:
- 251451-30-6
- MF:
- C16H21N3O3
- Structure:
- Chemical Name:
- 11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepine-2-carbaldehyde
- CAS:
- 2519517-78-1
- MF:
- C20H22ClNO2
- Structure:
- Chemical Name:
- 11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepine-2-carbaldehyde
- CAS:
- 2519517-78-1
- MF:
- C20H22ClNO2
- Structure:
- Chemical Name:
- 11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepine-2-carbaldehyde
- CAS:
- 2519517-78-1
- MF:
- C20H22ClNO2
- Chemical Name:
- Ganciclovir EP Impurity
- Chemical Name:
- Crisaborole Impurity 15
- Chemical Name:
- Latamoxef impurity A
- Structure:
- Chemical Name:
- 5,8-Dihydroxy-1,4-bis-[2-(2-hydroxy-ethylamino)-ethylamino]-2,3-dihydro-anthraquinone
- CAS:
- 70476-74-3
- MF:
- C22H30N4O6
- Chemical Name:
- (E)-methyl 3-(((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate
- Structure:
- Chemical Name:
- 4-Acetyl-2-fluorobiphenyl
- CAS:
- 42771-79-9
- MF:
- C14H11FO
- Structure:
- Chemical Name:
- m-xylene-4,alpha,alpha'-triol
- CAS:
- 2937-60-2
- MF:
- C8H10O3
- Structure:
- Chemical Name:
- Benzonitrile, 2-[(3,4-dihydro-6-methoxy-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl)methyl]-
- CAS:
- 2514763-78-9
- MF:
- C14H13N3O3
- Structure:
- Chemical Name:
- 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 3-[(1E)-2-(4-methyl-5-thiazolyl)ethenyl]-8-oxo-7-[(2-phenylacetyl)amino]-, (4-methoxyphenyl)methyl ester, (6R,7R)-
- CAS:
- 104146-11-4
- MF:
- C29H27N3O5S2
- Chemical Name:
- Dapagliflozin Impurity 46
- Chemical Name:
- Brexpiprazole Impurity ABCDEFGHJKL
- Structure:
- Chemical Name:
- p,p'-(2-pyridylmethylene)bisphenol
- CAS:
- 603-41-8
- MF:
- C18H15NO2
- Chemical Name:
- Tazobactam Impurity DBT
- Structure:
- Chemical Name:
- diginatin
- CAS:
- 52589-12-5
- MF:
- C41H64O15
- Structure:
- Chemical Name:
- Thiophene, 2-(2-fluorophenyl)-5-[(5-iodo-2-methylphenyl)methyl]-
- CAS:
- 2436275-33-9
- MF:
- C18H14FIS
- Chemical Name:
- 3-Chloro Avanafil
- Structure:
- Chemical Name:
- Revefenacin Impurity 2
- CAS:
- 1158699-78-5
- MF:
- C14H17NO4
- Structure:
- Chemical Name:
- (R)-2-(4-Methoxyphenyl)-1-methylethanamine
- CAS:
- 58993-79-6
- MF:
- C10H15NO
- Chemical Name:
- Troxipide Impurity 6
- Chemical Name:
- Piperacillin Impurity K
- Structure:
- Chemical Name:
- 3-Thiophenecarboxylic acid, 4-methyl-5-(4-nitrophenyl)-2-[(propoxycarbonyl)amino]-, ethyl ester
- CAS:
- 2591260-03-4
- MF:
- C18H20N2O6S
- Chemical Name:
- Pemetrexed disodium Impurity 32
- Structure:
- Chemical Name:
- Androsta-1,4-diene-17-carboxylic acid, 11,16,17-trihydroxy-3-oxo-, (11β,16α,17α)-
- CAS:
- 1185143-75-2
- MF:
- C20H26O6
- Chemical Name:
- Tazobactam Impurity LTE
- Chemical Name:
- Isavuconazole Impurity 47
- Structure:
- 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-(benzyloxy)quinolin-2(1H)-one)
- CAS:
- 753498-27-0
- MF:
- C49H49N3O6
- Structure:
- Chemical Name:
- Eltrombopag Impurity 37
- CAS:
- 350024-70-3
- MF:
- C14H18N2O
- Structure:
- Chemical Name:
- (S)-N-(2-(1-(3-ethoxy-4-methoxyphenyl)-2-((2-hydroxyethyl)sulfonyl)ethyl)-1,3-dioxoisoindolin-4-yl)acetamide
- MF:
- C23H26N2O8S
- Structure:
- Chemical Name:
- 2-(4-(2-(4-(1-(2-ethoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropan-1-ol
- MF:
- C28H39N3O2
- Chemical Name:
- Tafluprost Impurity 20
- Chemical Name:
- Rosuvastatin Impurity 149
- Structure:
- Chemical Name:
- 2-CHLOROMETHYL-5-TRIFLUOROMETHYL-[1,3,4]OXADIAZOLE
- CAS:
- 723286-98-4
- MF:
- C4H2ClF3N2O
- Chemical Name:
- Rifampicin Quinone Oxide
- Structure:
- Chemical Name:
- 1-Phenyl-3,4-dihydroisoquinoline
- CAS:
- 52250-50-7
- MF:
- C15H13N
- Structure:
- Chemical Name:
- Pyrazinecarboxamide, 3,6-difluoro- (9CI)
- CAS:
- 356783-29-4
- MF:
- C5H3F2N3O
- Structure:
- Chemical Name:
- Benzamide, 3-hydrazino- (9CI)
- CAS:
- 473927-51-4
- MF:
- C7H9N3O
- Structure:
- Chemical Name:
- 2-Pyrrolidinone, 3,4-dihydroxy-5-(hydroxymethyl)-, (3R,4R,5R)- (9CI)
- CAS:
- 155102-96-8
- MF:
- C5H9NO4
- Chemical Name:
- Bumetanide Impurity 24
- Chemical Name:
- Rocuronium Bromide Impurity 37、38、39
- Chemical Name:
- Ritonavir EP Impurity HIJ
- Chemical Name:
- Crisaborole Impurity 42
- Structure:
- Chemical Name:
- 2,3-DICHLOROPYRIDINE-5-CARBONYL CHLORIDE
- CAS:
- 54127-29-6
- MF:
- C6H2Cl3NO