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:
- α-Desmethyl Anastrozole
- CAS:
- 1215780-15-6
- MF:
- C16H17N5
- Structure:
- Chemical Name:
- Epi Lovastatin
- CAS:
- 79952-44-6
- MF:
- C24H36O5
- Structure:
- Chemical Name:
- Hydroxy Brimonidine
- CAS:
- 1216379-05-3
- MF:
- C11H12BrN5O
- Structure:
- Chemical Name:
- 1-(1H-benzo[d]imidazol-2-yl)-3-methyl-4-oxo-1,4-dihydropyridine-2-carboxylic acid
- CAS:
- 1163685-30-0
- MF:
- C14H11N3O3
- Structure:
- Chemical Name:
- 7-Methoxy-3,4-dihydro-1H-quinolin-2-one
- CAS:
- 22246-17-9
- MF:
- C10H11NO2
- Structure:
- Chemical Name:
- 4-Methoxy-alpha-methyl-N-(phenylmethyl)benzeneethanamine hydrochloride
- CAS:
- 1049695-95-5
- MF:
- C17H21NO.HCl
- Structure:
- Chemical Name:
- Montelukast Methyl Ketone
- CAS:
- 937275-23-5
- MF:
- C34H32ClNO3S
- Structure:
- Chemical Name:
- Propyl Itraconazole
- CAS:
- 74855-91-7
- MF:
- C34H36Cl2N8O4
- Structure:
- Chemical Name:
- Olmesartan Methyl Ketone
- CAS:
- 1227626-45-0
- MF:
- C25H28N6O2
- Structure:
- Chemical Name:
- (N-tert-Butoxycarbonyl-N-[(1'R)-hydroxy-1-phenyl)ethyl])-4-nitrophenylethylaMine
- CAS:
- 223673-35-6
- MF:
- C21H26N2O5
- Structure:
- Chemical Name:
- 3-methyleneisobenzofuran-1(3H)-one
- CAS:
- 3453-63-2
- MF:
- C9H6O2
- Structure:
- Chemical Name:
- Irbesartan impurity A
- MF:
- C25H28N6O
- Structure:
- Chemical Name:
- Azelastine N-Oxide
- CAS:
- 640279-88-5
- MF:
- C22H24ClN3O2
- Structure:
- Chemical Name:
- Desloratadine Hydroxypiperidine N-Oxide
- CAS:
- 1193725-75-5
- MF:
- C19H15ClN2O2
- Structure:
- Chemical Name:
- 16α,17,21-Trihydroxy-pregna-1,4-diene-3,11,20-trione
- CAS:
- 3754-05-0
- MF:
- C21H26O6
- Structure:
- Chemical Name:
- 4H-Furo[2,3-c]pyranyl Mupirocin SodiuM IMpurity
- CAS:
- 116182-43-5
- MF:
- C26H43NaO9
- Structure:
- Chemical Name:
- 4-Methyl Erlotinib Hydrochloride
- CAS:
- 1346601-52-2
- MF:
- C23H25N3O4
- Structure:
- Chemical Name:
- 5-[[(4-Fluorophenyl)Methyl]aMino]-1,3-dihydro-2H-iMidazo[4,5-b]pyridin-2-one
- CAS:
- 951624-49-0
- MF:
- C13H11FN4O
- Structure:
- Chemical Name:
- (D-LYS16)-ACTH (1-24) (HUMAN, BOVINE, MOUSE, OVINE, PORCINE, RABBIT, RAT)
- CAS:
- 494750-52-6
- MF:
- C136H210N40O31S
- Structure:
- Chemical Name:
- 1-(diaminomethylidene)-3-[(2R,3R,4R,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]urea
- CAS:
- 2508-80-7
- MF:
- C7H14N4O5
- Structure:
- Chemical Name:
- 3-(2-amino-1-hydroxyethyl)benzene-1,2-diol
- CAS:
- 73660-93-2
- MF:
- C8H11NO3
- Structure:
- Chemical Name:
- 3-(4-Methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)benzonitrile
- CAS:
- 641571-12-2
- MF:
- C12H8F3N3
- Structure:
- Chemical Name:
- 17-BETA-ESTRADIOL 3-METHYL ETHER
- CAS:
- 1474-53-9
- MF:
- C19H26O3
- Structure:
- Chemical Name:
- 7-Epi-10-oxo-docetaxel (Docetaxel Impurity D)
- CAS:
- 162784-72-7
- MF:
- C43H51NO14
- Structure:
- Chemical Name:
- (3-CHLORO-3-PHENYL-PROPYL)-DIMETHYL-AMINE HYDROCHLORIDE
- CAS:
- 79130-51-1
- MF:
- C11H16ClN
- Structure:
- Chemical Name:
- (Dimethylamino)acetaldehyde Dimethyl Acetal
- CAS:
- 38711-20-5
- MF:
- C6H15NO2
- Structure:
- Chemical Name:
- Dasatinib N-Oxide
- CAS:
- 910297-52-8
- MF:
- C22H26ClN7O3S
- Structure:
- Chemical Name:
- (R)-9-[2-(DIETHYLPHOSPHONOMETHOXY)PROPYL] ADENINE
- CAS:
- 180587-75-1
- MF:
- C13H22N5O4P
- Structure:
- Chemical Name:
- P-TOLYL-PROPYNOIC ACID ETHYL ESTER
- CAS:
- 52188-06-4
- MF:
- C12H12O2
- Structure:
- Chemical Name:
- cis-N-Methyl-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-1-naphthalenamine hydrochloride
- CAS:
- 79617-89-3
- MF:
- C17H17Cl2N.HCl
- Structure:
- Chemical Name:
- Pseudomonic acid C
- CAS:
- 71980-98-8
- MF:
- C26H44O8
- Structure:
- Chemical Name:
- Cytarabine Impurity 12
- CAS:
- 14057-18-2
- MF:
- C15H18N2O9
- Structure:
- Chemical Name:
- D,L-O-DesMethyl Venlafaxine-d6
- CAS:
- 1062605-69-9
- MF:
- C16H19D6NO2
- Structure:
- Chemical Name:
- Perindoprilat LactaM B
- CAS:
- 130061-28-8
- MF:
- C17H26N2O4
- Structure:
- Chemical Name:
- PseudoMonic Acid D SodiuM
- CAS:
- 85178-60-5
- MF:
- C26H41NaO9
- Structure:
- Chemical Name:
- Parent nucleus of cefotiaM hydrochloride
- CAS:
- 372092-19-8
- MF:
- C13H21N7O3S2
- Structure:
- Chemical Name:
- Bisacodyl Related Compound E (20 mg) (2-[(4-Acetoxyphenyl)(pyridin-2-yl)methyl]phenyl acetate)
- CAS:
- 111664-35-8
- MF:
- C22H19NO4
- Structure:
- Chemical Name:
- EsoMeprazole related substance H431/41
- CAS:
- 1227380-90-6
- MF:
- C16H15N3O4
- Structure:
- Chemical Name:
- (3S,4R)-4-(4-Fluorophenyl)piperidine-3-Methanol Hydrochloride
- CAS:
- 220548-73-2
- MF:
- C12H17ClFNO
- Structure:
- Chemical Name:
- LaMotrigine IMpurity D
- CAS:
- 661463-79-2
- MF:
- C9H5Cl2N3O2
- Structure:
- Chemical Name:
- (3β)-17-(3-Pyridinyl)androsta-5,16-dien-3-ol N-Oxide Sulfate
- MF:
- C24H31NO5S
- Structure:
- Chemical Name:
- DeMethylpiperazinyl Desethyl Sildenafil Sulfonyl Chloride
- CAS:
- 139756-27-7
- MF:
- C15H15ClN4O4S
- Structure:
- Chemical Name:
- Rizatriptan IMpurity B
- CAS:
- 1016900-28-9
- MF:
- C13H15ClN5
- Structure:
- Chemical Name:
- rac Adrenaline IMpurity D
- CAS:
- 1095714-91-2
- MF:
- C16H19NO3
- Structure:
- Chemical Name:
- 2-(1-Methylethenyl)-6-(1-Methylethyl)phenol
- CAS:
- 74926-89-9
- MF:
- C12H16O
- Structure:
- Chemical Name:
- Irinotecan IMpurity G
- CAS:
- 947687-02-7
- MF:
- C35H42N4O6
- Structure:
- Chemical Name:
- 5-[Bis(2-hydroxyethyl)aMino]-1-Methyl-1H-benziMidazole-2-butanoic Acid
- CAS:
- 109882-30-6
- MF:
- C16H23N3O4
- Structure:
- Chemical Name:
- 5-Chloro-6'-Methyl-3-[4-(Methylsulfonyl)phenyl]-2,3'-bipyridine 1'-Oxide
- CAS:
- 325855-74-1
- MF:
- C18H15ClN2O3S
- Structure:
- Chemical Name:
- Lafutidine IMpuritiy B
- CAS:
- 174583-84-7
- MF:
- C22H29N3O5S
- Structure:
- Chemical Name:
- N-(Methylsulfonyl)-N-(2-phenoxyphenyl)MethanesulfonaMide
- CAS:
- 905858-63-1
- MF:
- C14H15NO5S2
- Structure:
- Chemical Name:
- 4,5-Dihydro-α,3-diMethyl-5-oxo-1-phenyl-α-sulfo-1H-pyrazole-4-acetic Acid
- CAS:
- 1357477-99-6
- MF:
- C13H14N2O6S
- Structure:
- Chemical Name:
- tert-butyl 4-(2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)Methyl)benzoyl)piperazine-1-carboxylate
- CAS:
- 763114-04-1
- MF:
- C25H27FN4O4
- Structure:
- Chemical Name:
- 1H-IMidazole, 4-Methyl-1-[3-nitro-5-(trifluoroMethyl)phenyl]-
- CAS:
- 916975-92-3
- MF:
- C11H8F3N3O2
- Structure:
- Chemical Name:
- Edaravone iMpurity P3
- CAS:
- 1323485-71-7
- MF:
- C13H16N2O4S
- Structure:
- Chemical Name:
- Hesperidin methylchalcone
- CAS:
- 24292-52-2
- MF:
- C29H36O15
- Structure:
- Chemical Name:
- Ethyl 5,6-dichloro-3,4-dihydro-2(1H)-iminoquinazoline-3-acetate hydrobromide
- CAS:
- 70381-75-8
- MF:
- C12H14BrCl2N3O2
- Structure:
- Chemical Name:
- 4-(3,4-Dichlorophenyl)-1,2,3,4-Tetrahydro-
- CAS:
- 79617-95-1
- MF:
- C17H17Cl2N
- Chemical Name:
- Avatrombopag Impurity 77
- Chemical Name:
- methyl 5-((4-(3-carbamoyl-1-(4-methoxyphenyl)-7-oxo-1,4,5,7-tetrahydro-6H-pyrazolo[3,4-c]pyridin-6-yl)phenyl)amino)pentanoate
- Chemical Name:
- N-(4-((3-chloro-4-fluorophenyl)amino)-7-fluoroquinazolin-6-yl)-4-(dimethylamino)butanamide
- Chemical Name:
- Ertapenem Impurity A(USP)
- Structure:
- Chemical Name:
- D-Glutamic acid, 4-(cyanomethyl)-N-[(1,1-dimethylethoxy)carbonyl]-, 1,5-dimethyl ester, (4S)-rel-
- CAS:
- 2740644-40-8
- MF:
- C14H22N2O6
- Structure:
- Chemical Name:
- INDEX NAME NOT YET ASSIGNED
- CAS:
- 2731089-65-7
- MF:
- C27H34N2O6
- Structure:
- Chemical Name:
- Cyclopentanecarboxylic acid, 3-[(1S)-1-(acetylamino)-2-ethylbutyl]-4-amino-2-hydroxy-, methyl ester, (1S,2S,3R,4R)-, mono(trifluoroacetate) (salt) (9CI)
- CAS:
- 357448-34-1
- MF:
- C17H29F3N2O6
- Chemical Name:
- Dobutamine Impurity 16
- Chemical Name:
- Dobutamine Impurity 16
- Chemical Name:
- Faropenem Impurity AB
- Chemical Name:
- Nirmatrelvir Impurity 9
- Structure:
- Chemical Name:
- trans N-Benzyl Paroxetine
- CAS:
- 105813-14-7
- MF:
- C26H26FNO3
- Chemical Name:
- Lasmiditan Impurity 10
- Chemical Name:
- Nilotinib N-Oxide Impurity 3
- Chemical Name:
- Amoxicillin Impurity U(EP)
- Structure:
- Chemical Name:
- Benzonitrile, 2-[(4-chloro-3,6-dihydro-2,6-dioxo-1(2H)-pyrimidinyl)methyl]-
- CAS:
- 2749357-07-9
- MF:
- C12H8ClN3O2
- Chemical Name:
- Odaterol Impurity 36
- Chemical Name:
- Odaterol Impurity 36
- Chemical Name:
- Odaterol Impurity 36
- Structure:
- Chemical Name:
- 3,3',5,5'-TETRAIODOTHYRO-ACETIC ACID
- CAS:
- 67-30-1
- MF:
- C14H8I4O4
- Chemical Name:
- Avatrombopag Impurity 58
- Chemical Name:
- Avatrombopag Impurity 58
- Structure:
- Chemical Name:
- 4-Methoxyglucobrassicin
- CAS:
- 83327-21-3
- MF:
- C17H22N2O10S2
- Structure:
- Chemical Name:
- 4-methylsulfinylbenzoate
- CAS:
- 33963-58-5
- MF:
- C8H8O3S
- Chemical Name:
- Capecitabine Related Compound C
- Structure:
- Chemical Name:
- 2-Cyclopentene-1-methanol, 4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-, (1R-cis)-
- CAS:
- 136470-79-6
- MF:
- C14H18N6O
- Structure:
- Chemical Name:
- Glycopyrrolate Erythro Isomer
- CAS:
- 201667-20-1
- Structure:
- Chemical Name:
- 1,2-Benzenedicarboxylicacid,3-(hydroxyamino)-(9CI)
- CAS:
- 202262-76-8
- MF:
- C8H7NO5
- Chemical Name:
- Oprinone Impurity 1
- Structure:
- Chemical Name:
- 5-chloro-N-(4,5-dihydro-1H-imidazol-2-yl)quinoxalin-6-amine
- CAS:
- 91147-46-5
- MF:
- C11H10ClN5
- Structure:
- Chemical Name:
- (S)-(+)-3-HYDROXYTETRAHYDROFURAN
- CAS:
- 79107-75-8
- MF:
- C4H8OS
- Structure:
- Chemical Name:
- TRIBENZYLPHOSPHITE
- CAS:
- 15205-57-9
- MF:
- C21H21O3P
- Structure:
- Chemical Name:
- 4-Chlor-3-nitro-5-sulfobenzoesure
- CAS:
- 130262-91-8
- MF:
- C7H4ClNO7S
- Structure:
- Chemical Name:
- 4-(4-Methylpiperazin-1-ylmethyl)benzoic acid
- CAS:
- 106261-48-7
- MF:
- C13H18N2O2
- Structure:
- Chemical Name:
- Diphenylpiperidin-4-ylmethanol hydrochloride
- CAS:
- 1798-50-1
- MF:
- C18H22ClNO
- Structure:
- Chemical Name:
- 2,4-DIMETHYLDIPHENYLSULFIDE
- CAS:
- 16704-47-5
- MF:
- C14H14S
- Structure:
- Chemical Name:
- Dibenz[b,e]oxepin-11(6H)-one
- CAS:
- 4504-87-4
- MF:
- C14H10O2
- Structure:
- Chemical Name:
- 2-CHLORO-1-(4,5-DICHLORO-2-THIENYL)ETHAN-1-ONE
- CAS:
- 64218-50-4
- MF:
- C6H3Cl3OS
- Structure:
- Chemical Name:
- (5Z,7E)-9,10-Seco-26,27-cyclo-1α,3β-dihydroxycholesta-5,7,10(19)-trien-24-one
- CAS:
- 126860-84-2
- MF:
- C27H40O3
- Structure:
- Chemical Name:
- (-)-3-Demethylcolchicine
- CAS:
- 7336-33-6
- MF:
- C21H23NO6
- Structure:
- Chemical Name:
- (E)-3-[p-Bromomethylphenyl]acrylic acid ethyl ester
- CAS:
- 78712-67-1
- MF:
- C12H13BrO2
- Structure:
- Chemical Name:
- 3-Amino-2-butenoic acid
- CAS:
- 21112-45-8
- MF:
- C4H7NO2