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:
- N-(2,6-dimethylphenyl)-2-((2,6-dimethylphenyl)amino)acetamide
- CAS:
- 294852-91-8
- MF:
- C18H22N2O
- Structure:
- Chemical Name:
- N6-propyl-3a,4,5,6,7,7a-hexahydrobenzo[d]thiazole-2,6-diamine
- CAS:
- 1052691-22-1
- MF:
- C10H19N3S
- Structure:
- Chemical Name:
- (E)-N-(2-(7-methoxy-3,4-dihydronaphthalen-1(2H)-ylidene)ethyl)acetamide
- CAS:
- 178677-39-9
- MF:
- C15H19NO2
- Structure:
- Chemical Name:
- (Z)-methyl 3-(((4-(methylamino)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate
- CAS:
- 1987887-92-2
- MF:
- C24H21N3O3
- Structure:
- Chemical Name:
- 1-(prop-1-en-2-yl)-3-(2-(4-(3-(trifluoromethyl)phenyl)piperazin-1-yl)ethyl)-1H-benzo[d]imidazol-2(3H)-one
- CAS:
- 1971858-36-2
- MF:
- C23H25F3N4O
- Structure:
- Chemical Name:
- 2-(3-(methylamino)-1-(thiophen-2-yl)propyl)naphthalen-1-ol
- CAS:
- 1033803-59-6
- MF:
- C18H19NOS
- Structure:
- Chemical Name:
- Bendamustine Desmethyl Impurity
- CAS:
- 41515-13-3
- MF:
- C15H19Cl2N3O2
- Structure:
- Chemical Name:
- (R)-N,N-dimethyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine
- CAS:
- 878757-08-5
- MF:
- C19H21NOS
- Structure:
- Chemical Name:
- Apixaban Impurity 17
- CAS:
- 2204368-51-2
- MF:
- C29H31N5O5
- Chemical Name:
- Aprepitant Impurity 24
- Chemical Name:
- Aripiprazole Impurity 11
- Chemical Name:
- Avanafil Impurity 10
- Chemical Name:
- Capecitabine Impurity 10
- Chemical Name:
- Carfilzomib Impurity C
- Structure:
- Chemical Name:
- Cefathiamidine Impurity 4
- CAS:
- 1418224-75-5
- MF:
- C10H11BrN2O5S
- Chemical Name:
- Cefodizime Impurity 2
- Structure:
- Chemical Name:
- Choline Fenofibrate Impurity 1
- CAS:
- 2985-79-7
- MF:
- C13H9ClO2
- Chemical Name:
- DecitaBine Impurity 11
- Chemical Name:
- Isavuconazole Impurity 21
- Chemical Name:
- Isavuconazole Impurity 27
- Chemical Name:
- Istradefylline Impurity E
- Chemical Name:
- Linagliptin Impurity 41
- Chemical Name:
- PalBociclib Impurity 17
- Chemical Name:
- PalBociclib Impurity 24
- Chemical Name:
- Posaconazole Impurity 12
- Structure:
- Chemical Name:
- Posaconazole Impurity 24
- CAS:
- 165115-78-6
- MF:
- C19H20F2O2
- Structure:
- Chemical Name:
- Sitagliptin Impurity 24
- CAS:
- 2349567-54-8
- MF:
- C15H19F2NO4
- Structure:
- Chemical Name:
- Tamoxifen EP Impurity H
- CAS:
- 809285-09-4
- MF:
- C43H48N2O2
- Chemical Name:
- Tenofovir impurity Q
- Structure:
- Chemical Name:
- Trelagliptin Impurity 20
- CAS:
- 1821520-42-6
- MF:
- C20H22FN5O3
- Structure:
- Chemical Name:
- Umeclidinium Impurity 3
- CAS:
- 869113-45-1
- MF:
- C29H32BrNO3
- Structure:
- Chemical Name:
- Vardenafil Impurity 7
- CAS:
- 448184-56-3
- MF:
- C21H26N6O7S
- Structure:
- Chemical Name:
- Moxifloxacin Related Compound A (HCl salt form)
- CAS:
- 151282-23-4
- MF:
- C20H22ClF2N3O3
- Structure:
- Chemical Name:
- 8-Hydroxy Entecavir
- CAS:
- 1795791-10-4
- MF:
- C12H15N5O4
- Structure:
- Chemical Name:
- 1-Pyrrolidinecarboxylic acid, 4-[4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)-1-piperazinyl]-2-(3-thiazolidinylcarbonyl)-, 1,1-dimethylethyl ester, (2S,4R)-
- CAS:
- 1404559-22-3
- MF:
- C27H38N6O3S
- Chemical Name:
- Ampicillin Impurity A
- Chemical Name:
- Cefditoren Pivoxil Dimer
- Chemical Name:
- Cefixime Impurity A(EP)
- Chemical Name:
- Oxacillin Sodium Impurity B(EP)
- Structure:
- Chemical Name:
- 3,5-dichlorothiophene-2-carboxylic acid
- CAS:
- 89166-94-9
- MF:
- C5H2Cl2O2S
- Structure:
- Chemical Name:
- Brexpiprazole Impurity 2
- CAS:
- 2094559-58-5
- MF:
- C38H40N4O4S
- Structure:
- Chemical Name:
- 2-methyl-6-oxo-1,6-dihydro-[3,4'-bipyridine]-5-carboxylic acid
- CAS:
- 80047-38-7
- MF:
- C12H10N2O3
- Structure:
- Chemical Name:
- Levofloxacin Impurity 7
- CAS:
- 1607796-83-7
- MF:
- C15H14FNO5
- Chemical Name:
- Moxifloxacin EP Impurity E HCl
- Structure:
- Chemical Name:
- Pantoprazole Impurity 11
- CAS:
- 172282-50-7
- MF:
- C7H8F2N2O
- Structure:
- Chemical Name:
- Solifenacin Related Compound 24
- CAS:
- 1682642-69-8
- MF:
- C15H23ClN2
- Structure:
- Chemical Name:
- Ticagrelor Related Compound 44
- CAS:
- 1431867-40-1
- MF:
- C8H12ClN3OS
- Structure:
- Chemical Name:
- (trans)-2-(3,4-difluorophenyl)cyclopropanecarboxamide
- CAS:
- 1006614-51-2
- MF:
- C10H9F2NO
- Structure:
- Chemical Name:
- 2-cyano-N-methyl-N-((3R,4R)-4-methyl piperidin-3-yl) Acetamide hydrochloride
- CAS:
- 1640971-87-4
- MF:
- C10H18ClN3O
- Structure:
- Chemical Name:
- 6-methyl-N1-(4-methyl-6-(pyridin-3-yl)pyrimidin-2-yl)benzene-1,3-diamine
- MF:
- C17H17N5
- Structure:
- Chemical Name:
- 5-METHOXY-2-BENZIMIDAZOLINONE
- CAS:
- 2080-75-3
- MF:
- C8H8N2O2
- Structure:
- Chemical Name:
- WPDCFRNNHUYQGW-IUXPMGMMSA-N
- CAS:
- 1628639-06-4
- MF:
- C21H23NO4
- Structure:
- Chemical Name:
- tert-Butyl 2-((4S,6S)-6-(chloromethyl(02,2-1,3-dioxan-4-yl)acetate
- CAS:
- 521974-00-5
- MF:
- C13H23ClO4
- Structure:
- Chemical Name:
- Cefadroxil Sulfoxide
- CAS:
- 182290-77-3
- MF:
- C16H17N3O6S
- Structure:
- Chemical Name:
- 4'-FLUOROCYCLOPROPANECARBOXANILIDE
- CAS:
- 2354-89-4
- MF:
- C10H10FNO
- Structure:
- Chemical Name:
- (2R,4S)-4-([1,1'-Biphenyl]-4-ylmethyl)-2-methyl-4-(2,5-dioxopyrrolidin-1-yl)butanoic acid
- CAS:
- 1639970-62-9
- MF:
- C22H23NO4
- Structure:
- Chemical Name:
- 1-(4-(2-methyl-6-oxopiperidin-1-yl)phenyl)-3-morpholino-5,6-dihydropyridin-2(1H)-one
- CAS:
- 2098457-93-1
- MF:
- C21H27N3O3
- Structure:
- Chemical Name:
- 5-ethyl 3-isopropyl 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
- CAS:
- 2170716-02-4
- MF:
- C22H29ClN2O5
- Structure:
- Chemical Name:
- Acetamide,N-(2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl)-
- CAS:
- 6118-65-6
- MF:
- C10H8N2O3
- Chemical Name:
- Ibrutinib impurity D
- Structure:
- Chemical Name:
- Mupirocin impurity A
- MF:
- C26H44O9
- Structure:
- Chemical Name:
- Aurantio-obtusin-6-O-β-D-glucoside
- CAS:
- 129025-96-3
- MF:
- C23H24O12
- Structure:
- Chemical Name:
- FG-4592 intermediate7
- CAS:
- 1509958-19-3
- MF:
- C20H20N2O4
- Structure:
- Chemical Name:
- Milnacipran Impurity 13
- CAS:
- 710339-49-4
- MF:
- C12H16NO+
- Chemical Name:
- Ofloxacin/Levofloxacin Impurity A
- Chemical Name:
- Urapidil Impurity A
- Chemical Name:
- Tofacitinib Impurity I
- Structure:
- Chemical Name:
- N-(3-chloro-4-fluorophenyl)-6 ,7-dimethoxyquinazolin-4-amine
- CAS:
- 153437-78-6
- MF:
- C16H13ClFN3O2
- Structure:
- Chemical Name:
- Itopride Impurity C
- CAS:
- 141996-97-6
- MF:
- C19H24N2O4
- Structure:
- Chemical Name:
- Mirabegron Impurity
- CAS:
- 1796931-48-0
- MF:
- C21H24N4O2S
- Chemical Name:
- Nicorandil Impurity 1
- Chemical Name:
- Piperacillin Impurity 6
- Structure:
- Chemical Name:
- Bosutinib Impurity 5
- CAS:
- 1391063-17-4
- MF:
- C26H29Cl2N5O3
- Chemical Name:
- Afatinib Impurity 14
- Structure:
- Chemical Name:
- methyl(E)-4-(methylamino)but-2-enoate
- CAS:
- 915788-22-6
- MF:
- C6H11NO2
- Chemical Name:
- Levomilnacipran impurity
- Chemical Name:
- Sofosbuvir IMpurity 4
- Structure:
- Chemical Name:
- 1,3-bis(4-isobutylphenyl)butan-1-one
- MF:
- C24H32O
- Structure:
- Chemical Name:
- 6-isobutyl-3-methyl-2,3-dihydro-1H-inden-1-one
- CAS:
- 1340024-54-5
- MF:
- C14H18O
- Structure:
- Chemical Name:
- Edoxaban impurity 1
- CAS:
- 41374-72-5
- MF:
- C9H10N2O3
- Chemical Name:
- Canagliflozin Impurity 18
- Chemical Name:
- Canagliflozin Impurity 23
- Chemical Name:
- Carfilzomib Impurity 4
- Structure:
- Chemical Name:
- Lenvatinib Impurity 2
- CAS:
- 2380197-90-8
- MF:
- C28H22ClN5O5
- Structure:
- Chemical Name:
- FeBuxostat Impurity 33
- CAS:
- 100118-38-5
- MF:
- C12H14O5
- Structure:
- Chemical Name:
- (S)-3-(4-phenoxyphenyl)-1-(piperidin-3-yl)
- CAS:
- 1642630-12-3
- MF:
- C22H22N6O
- Structure:
- Chemical Name:
- Latamoxef Impurity 1
- CAS:
- 75007-70-4
- MF:
- C19H20N6O7S
- Structure:
- Chemical Name:
- Amlodipine iMpurity K
- CAS:
- 1809326-44-0
- MF:
- C18H21ClN2O5
- Structure:
- Chemical Name:
- Cabozantinib impurity 4
- CAS:
- 95932-39-1
- MF:
- C11H15NO3
- Structure:
- Chemical Name:
- Rosuvastatin EP Impurity C
- CAS:
- 1620823-61-1
- MF:
- C22H27FN3NaO6S
- Structure:
- Chemical Name:
- 6,7-bis(2-methoxyethoxy)-N-phenylquinazolin-4-amine
- CAS:
- 1145671-52-8
- MF:
- C20H23N3O4
- Structure:
- Chemical Name:
- (3R,4R,5S)-ethyl 4-acetamido-5-amino-3-isopropoxycyclohex-1-enecarboxylate
- CAS:
- 1052063-36-1
- MF:
- C14H24N2O4
- Structure:
- Chemical Name:
- 4-(N-(tert-butyl)acetamido)-5-(diallylamino)-3-(pentan-3-yloxy)cyclohex-1-enecarboxylate
- CAS:
- 941296-96-4
- MF:
- C16H28N2O4
- Structure:
- Chemical Name:
- (2R,5S)-5-(4-amino-5-fluoro-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2-carboxylic acid
- MF:
- C8H8FN3O4S
- Structure:
- Chemical Name:
- Amlodipine Impurity 10
- CAS:
- 2170104-51-3
- MF:
- C26H31ClN2O8S
- Structure:
- Chemical Name:
- Apixaban Impurity 15
- CAS:
- 1466571-07-2
- MF:
- C21H20N4O4
- Structure:
- Chemical Name:
- Clopidogrel Impurity 8
- MF:
- C15H14ClNO2S
- Structure:
- Chemical Name:
- Acyclovir Impurity I: 7,9'-[Ethylene-bis(oxymethylene)] Bis (2-amino-1-9-dihydro-6H-purin-6-one)
- CAS:
- 1797832-75-7
- MF:
- C14H16N10O4
- Structure:
- Chemical Name:
- Nilotinib genotoxic impurity 3
- CAS:
- 915711-42-1
- MF:
- C19H17F3N4O
- Structure:
- Chemical Name:
- GSFIWDGFHNAUFU-UHFFFAOYSA-N
- CAS:
- 2125702-80-7
- MF:
- C16H29N5O4