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.
- Chemical Name:Bosutinib Impurity 15
- CAS:
- MF:
- Chemical Name:Ertapenem Impurity 2
- CAS:
- MF:
- Chemical Name:Febuxostat Impurity 68
- CAS:
- MF:
- Chemical Name:Indacaterol Impurity 9
- CAS:
- MF:
- Structure:

- Chemical Name:Olanzapine Impurity 22
- CAS:
- MF:C17H20N4S
- Structure:

- Chemical Name:Olopatadine Impurity 9
- CAS:680579-52-6
- MF:C39H36Br2P2
- Structure:

- Chemical Name:Oseltamivir Impurity 59
- CAS:2485836-60-8
- MF:C12H22N2O3
- Chemical Name:Palbociclib Impurity 36
- CAS:
- MF:
- Chemical Name:Regorafenib Impurity 34
- CAS:
- MF:
- Chemical Name:Rosuvastatin Impurity 47
- CAS:
- MF:
- Structure:

- Chemical Name:Sildenafil Impurity 36
- CAS:
- MF:C25H27N3O5
- Chemical Name:Sunitinib Impurity 4
- CAS:
- MF:
- Chemical Name:Tafluprost Impurity 11
- CAS:
- MF:
- Chemical Name:Tazobactam Impurity 4
- CAS:
- MF:
- Chemical Name:Ticagrelor Impurity 103
- CAS:
- MF:
- Chemical Name:Ticagrelor Impurity 94
- CAS:
- MF:
- Chemical Name:Tofacitinib Impurity 119
- CAS:
- MF:
- Chemical Name:Trelagliptin Impurity 26
- CAS:
- MF:
- Chemical Name:tirofiban Impurity 1 DIHCl
- CAS:
- MF:
- Structure:

- Chemical Name:Fingolimod 2-Phenethyl Analog
- CAS:851039-25-3
- MF:C35H57NO2
- Structure:

- Chemical Name:Ritonavir EP Impurity O
- CAS:1414933-81-5
- MF:C37H48N6O5S2
- Structure:

- Chemical Name:Entecavir Impurity 17(Entecavir EP Impurity C)
- CAS:2204369-23-1
- MF:C12H15N5O4
- Structure:

- Chemical Name:Gemcitabine Impurity 9
- CAS:2174019-90-8
- MF:C16H15F2N3O5
- Structure:

- Chemical Name:Sacubitril
- CAS:1361408-17-4
- MF:C18H20ClNO2
- Chemical Name:Empagliflozin Impurity 43
- CAS:
- MF:
- Structure:

- Chemical Name:1-tosyl-1,4,8,11-tetraazacyclotetradecane trihydrochloride
- CAS:128495-30-7
- MF:C17H31ClN4O2S
- Structure:

- Chemical Name:Fluconazole
- CAS:163921-62-8
- MF:C13H10F2N6
- Structure:

- Chemical Name:4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2-amine
- CAS:570407-42-0
- MF:C17H23ClN4S2
- Chemical Name:Trelagliptin Impurity 31
- CAS:
- MF:
- Chemical Name:Caspofungin impurity E
- CAS:
- MF:
- Chemical Name:Erythromycin Impurity C
- CAS:
- MF:
- Chemical Name:Itraconazole iMpurity 4
- CAS:
- MF:
- Chemical Name:Azacitidine Impurity 3
- CAS:
- MF:
- Chemical Name:Ozagrel Impurity 2
- CAS:
- MF:
- Chemical Name:Olaparib Impurity 22
- CAS:
- MF:
- Structure:

- Chemical Name:Irbesartan Impurity 14
- CAS:133690-91-2
- MF:C25H28N6O
- Structure:

- Chemical Name:Febuxostat Impurity 25
- CAS:1643131-89-8
- MF:C17H20N2O4S
- Structure:

- Chemical Name:Pregabalin Impurity 3
- CAS:1928754-83-9
- MF:C12H22O3
- Chemical Name:Bosutinib Impurity 6
- CAS:
- MF:
- Structure:

- Chemical Name:Ticagrelor Impurity 49
- CAS:2376278-80-5
- MF:C8H15NO3
- Chemical Name:Edoxaban Impurity 14
- CAS:
- MF:
- Structure:

- Chemical Name:Indacaterol Impurity 3
- CAS:2250243-41-3
- MF:C26H32N2O3
- Chemical Name:Canagliflozin Impurity 11
- CAS:
- MF:
- Chemical Name:Oseltamivir Impurity 22
- CAS:
- MF:
- Chemical Name:Riociguat IMpurtiy B
- CAS:
- MF:
- Structure:

- Chemical Name:Amlodipine Impurity 48
- CAS:39562-06-6
- MF:C18H20ClNO4
- Chemical Name:Silodosin Impurity C
- CAS:
- MF:
- Structure:

- Chemical Name:Dexmedetomidine-025
- CAS:2250242-52-3
- MF:C20H22N2
- Chemical Name:pranoprofen impurity 15
- CAS:
- MF:
- Structure:

- Chemical Name:Mono-Hydroxy Sugammadex
- CAS:2376607-99-5
- MF:C69H109NaO47S7
- Chemical Name:Metronidazole impurity A
- CAS:
- MF:
- Chemical Name:Sulpiride Impurity 6
- CAS:
- MF:
- Chemical Name:Cefminox Impurity A
- CAS:
- MF:
- Chemical Name:Cefminox Impurity F
- CAS:
- MF:
- Structure:

- Chemical Name:(R,E)-ethyl 5-([1,1'-biphenyl]-4-yl)-4-((tert-butoxycarbonyl)aMino)-2-Methylpent-2-enoate
- CAS:149709-59-1
- MF:C25H31NO4
- Structure:

- Chemical Name:1-(3-AMinopropyl)-4-(2-Methoxyphenyl)piperazine 97%
- CAS:20529-23-1
- MF:C14H23N3O
- Structure:

- Chemical Name:(2S,4R)-5-(Biphenyl-4-yl)-4-[(tert-butoxycarbonyl)amino]-2-methylpentanoic acid
- CAS:1012341-54-6
- MF:C23H29NO4
- Structure:

- Chemical Name:Calcium bis[4-{[(1S,3R)-1-([1,1'-biphenyl]-4-ylmethyl)-3-methyl-4-oxo-4-(propan-2-yloxyl)butyl]amino}-4-oxobutanoate]
- CAS:
- MF:C50H60CaN2O10
- Structure:

- Chemical Name:3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)benzamide
- CAS:917391-28-7
- MF:C12H10F3N3O
- Chemical Name:Alogliptin Impurity E
- CAS:
- MF:
- Chemical Name:Alogliptin Impurity E
- CAS:
- MF:
- Structure:

- Chemical Name:Carbamic acid, N-[(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-3,6-dihydro-4-methyl-2,6-dioxo-1(2H)-pyrimidinyl]-1-phenylethyl]-, 1,1-dimethylethyl ester
- CAS:830346-51-5
- MF:C33H32F5N3O5
- Structure:

- Chemical Name:Baicalein 6-O-glucoside
- CAS:28279-72-3
- MF:C21H20O10
- Structure:

- Chemical Name:(2S,3R)-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butane-2,3-diol
- CAS:135272-36-5
- MF:C12H13F2N3O2
- Structure:

- Chemical Name:Cycloocta[b]pyridine, 2-(4-ethyl-1-piperazinyl)-5,6,7,8,9,10-hexahydro-4-phenyl-
- CAS:132810-75-4
- MF:C23H31N3
- Structure:

- Chemical Name:(R)-1-(3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)propan-1-one
- CAS:1839099-22-7
- MF:C25H26N6O2
- Chemical Name:Linagliptin Impurity L
- CAS:
- MF:
- Structure:

- Chemical Name:Linagliptin Impurity S
- CAS:668273-74-3
- MF:C30H36N8O4
- Structure:

- Chemical Name:(R)-2-((6-(3-aminopiperidin-1-yl)-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzonitrile
- CAS:
- MF:C17H18FN5O2
- Structure:

- Chemical Name:2(1H)-Pyrimidinone,4-amino-1-b-D-arabinofuranosyl-, 3-oxide
- CAS:30902-36-4
- MF:C9H13N3O6
- Structure:

- Chemical Name:3,5-Pyridinedicarboxylicacid, 4-(2-chlorophenyl)-1,4-dihydro-2,6-dimethyl-, 3,5-diethyl ester
- CAS:34148-67-9
- MF:C19H22ClNO4
- Structure:

- Chemical Name:1-Propanamine,3-(dibenz[b,e]oxepin-11(6H)-ylidene)-N,N-dimethyl-, hydrochloride (1:1), (3Z)-
- CAS:25127-31-5
- MF:C19H22ClNO
- Structure:

- Chemical Name:Phenol, 4-(hydroxyamino)-
- CAS:3505-87-1
- MF:C6H7NO2
- Structure:

- Chemical Name:sodium:(2S)-2-[12-ethyl-8-(hydroxymethyl)-9-oxo-2-(4-piperidin-1-ylpiperidine-1-carbonyl)oxy-11H-indolizino[1,2-b]quinolin-7-yl]-2-hydroxybutanoate
- CAS:1329502-92-2
- MF:C33H41N4NaO7
- Structure:

- Chemical Name:QFJAHHNMKTWTGZ-DZAPPIOQSA-N
- CAS:2045402-27-3
- MF:C35H36ClNO4S
- Structure:

- Chemical Name:BJQMFFOQQWEWAF-DGBYXFBUSA-N
- CAS:1709825-83-1
- MF:C31H41ClO8
- Structure:

- Chemical Name:Vecuronium Bromide EP Impurity F
- CAS:18668-29-6
- MF:C26H41NO3
- Structure:

- Chemical Name:Imidafenacin Related Compound 11
- CAS:170105-09-6
- MF:C19H17N3
- Structure:

- Chemical Name:4-[3-(Hydroxymethyl)phenoxy]benzonitrile
- CAS:888967-63-3
- MF:C14H11NO2
- Structure:

- Chemical Name:(S)-3-Boc-5-(benzyloxy)-1-(chloromethyl)-9-methyl-2,3-dihydro-1H-benzo[e]indole
- CAS:945864-47-1
- MF:C26H28ClNO3
- Structure:

- Chemical Name:Acetaminophen Impurity B
- CAS:98966-17-7
- MF:C16H16N2O4
- Structure:

- Chemical Name:Furosemide Impurity 2
- CAS:
- MF:C12H11ClN2O5S
- Chemical Name:Ribavirin Impurity I
- CAS:
- MF:
- Chemical Name:Silodosin Impurity 2
- CAS:
- MF:
- Chemical Name:Tenofovir Impurity 52
- CAS:146297-30-5
- MF:
- Structure:

- Chemical Name:Amifostine Impurity 7
- CAS:174397-83-2
- MF:C7H16Br2N2
- Structure:

- Chemical Name:Amphotericin X1 (13-O-Methyl Amphotericin B)
- CAS:136135-57-4
- MF:C48H75NO17
- Chemical Name:Bendamustine Impurity 31
- CAS:
- MF:
- Structure:

- Chemical Name:Carbidopa Impurity 2
- CAS:1361017-74-4
- MF:C11H16N2O4
- Chemical Name:Cefazolin Impurity 2
- CAS:
- MF:
- Chemical Name:Cefminox Sodium Impurity 8
- CAS:
- MF:
- Chemical Name:Dapagliflozin Impurity 28
- CAS:
- MF:
- Structure:

- Chemical Name:Erlotinib Impurity 51
- CAS:115665-66-2
- MF:C8H6BrNO2
- Chemical Name:Oseltamivir Impurity 18
- CAS:
- MF:
- Chemical Name:Plerixafor Impurity 6
- CAS:
- MF:
- Structure:

- Chemical Name:Pregabalin Impurity 49
- CAS:1568110-05-3
- MF:C10H21NO2
- Structure:

- Chemical Name:Rivaroxaban Impurity 79
- CAS:1642601-00-0
- MF:C38H38N4O12
- Chemical Name:Rocuronium Bromide Impurity 37
- CAS:
- MF:
- Structure:

- Chemical Name:Rosuvastatin Impurity 4
- CAS:1899869-35-2
- MF:C19H22FN3O3S