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:
- Ticagrelor Impurity 40
- Chemical Name:
- Moxifloxacin Impurity 12
- Chemical Name:
- Cabozantinib Impurity 4
- Structure:
- Chemical Name:
- CHLOROAC-PRO-OH
- CAS:
- 23500-10-9
- MF:
- C7H10ClNO3
- Structure:
- Chemical Name:
- 2-Ethoxy-6-nitro-9-acridinamine
- CAS:
- 20304-70-5
- MF:
- C15H13N3O3
- Structure:
- Chemical Name:
- 4-O-Carboxymethyl-21-deoxy-20-hydroxy-21-oxorifamycin
- CAS:
- 15271-73-5
- MF:
- C39H47NO15
- Structure:
- Chemical Name:
- (3,4-Dimethoxyphenyl)isopropyl ketone
- CAS:
- 14046-55-0
- MF:
- C12H16O3
- Structure:
- Chemical Name:
- 2,3-Dichloro-5,6-diphenylpyrazine
- CAS:
- 57038-62-7
- MF:
- C16H10Cl2N2
- Structure:
- Chemical Name:
- DIDESMETHYL CITALOPRAM-D4
- CAS:
- 62498-69-5
- MF:
- C18H17FN2O
- Structure:
- Chemical Name:
- 2,4-Dihydro-4-[4-[4-(4-methoxyphenyl)-1-piperazinyl]phenyl]-2-(1-methylpropyl)-3H-1,2,4-triazol-3-one
- CAS:
- 252964-68-4
- MF:
- C23H29N5O2
- Structure:
- Chemical Name:
- 2-(2-Methoxyphenoxy)ethanol
- CAS:
- 18181-71-0
- MF:
- C9H12O3
- Structure:
- Chemical Name:
- 2-(3-Chloro-2-hydroxypropyl)-2H-isoindole-1,3-dione
- CAS:
- 19667-37-9
- MF:
- C11H10ClNO3
- Structure:
- Chemical Name:
- 4,6-Dibromo-m-cresol
- CAS:
- 13321-76-1
- MF:
- C7H6Br2O
- Structure:
- Chemical Name:
- 4-[(2,3-Dihydro-5,6-dimethoxy-1H-inden-2-yl)methyl]-1-(phenylmethyl)piperidine Hydrochloride
- CAS:
- 1034439-57-0
- MF:
- C24H32ClNO2
- Structure:
- Chemical Name:
- HYDROXY ITRACONAZOLE
- CAS:
- 112559-91-8
- MF:
- C35H38Cl2N8O5
- Structure:
- Chemical Name:
- (R)-SN-38
- CAS:
- 647852-82-2
- MF:
- C22H20N2O5
- Structure:
- Chemical Name:
- 5'-Deoxy-5-fluoro-N4-(isopentyloxycarbonyl)cytidine
- CAS:
- 162204-30-0
- MF:
- C15H22FN3O6
- Structure:
- Chemical Name:
- 5-(aminosulfonyl)-2-methoxybenzamide
- CAS:
- 52395-25-2
- MF:
- C8H10N2O4S
- Structure:
- Chemical Name:
- 1-HEXADECANOYL-2-(P-NITROPHENOXYSUCCINOYL)-SN-GLYCERYL-3-PHOSPHORYLCHOLINE
- CAS:
- 170569-87-6
- MF:
- C16H12F3N3O2S
- Structure:
- Chemical Name:
- PIPERIDINE-3-CARBOXYLIC ACID (2,6-DIMETHYL-PHENYL)-AMIDE
- CAS:
- 337488-90-1
- MF:
- C14H20N2O
- Structure:
- Chemical Name:
- N-Desmethyl Citalopram-d4 Oxalate
- CAS:
- 62498-68-4
- MF:
- C21H21FN2O5
- Structure:
- Chemical Name:
- Bis(3-hydroxypropyl) persulfide
- CAS:
- 30453-21-5
- MF:
- C6H14O2S2
- Structure:
- Chemical Name:
- 4-(2,3-DIMETHYL-BENZYL)-1H-IMIDAZOLE HCL H2O
- CAS:
- 90038-00-9
- MF:
- C12H17ClN2O
- Structure:
- Chemical Name:
- Metoprolol Acid Ethyl Ester
- CAS:
- 29112-40-1
- MF:
- C16H25NO4
- Structure:
- Chemical Name:
- 6-Hydroxy Desloratadine
- CAS:
- 119410-05-8
- MF:
- C19H19ClN2O
- Structure:
- Chemical Name:
- 10-Acetyloxy Oxcarbazepine
- CAS:
- 113952-21-9
- MF:
- C17H14N2O4
- Structure:
- Chemical Name:
- 9-[[2-(α-L-Alanyloxy)ethoxy]methyl]guanine Hydrochloride
- CAS:
- 84499-63-8
- MF:
- C11H17ClN6O4
- Structure:
- Chemical Name:
- Irinotecan Impurity 26
- CAS:
- 86639-51-2
- MF:
- C22H20N2O5
- Structure:
- Chemical Name:
- Bis(aminoethoxy) Amlodipine
- CAS:
- 721958-74-3
- MF:
- C22H30ClN3O6
- Structure:
- Chemical Name:
- 7,8,9,10-Dehydro Doxorubicinone
- CAS:
- 1159977-23-7
- MF:
- C21H14O8
- Structure:
- Chemical Name:
- 4-tert-Butyl-2,6-dimethyl-3-hydroxyphenylacetamide (Oxymetazoline hydrochloride impurity)
- CAS:
- 55699-13-3
- MF:
- C14H21NO2
- Structure:
- Chemical Name:
- (S)-N-Demethyl Dapoxetine
- CAS:
- 147199-39-1
- MF:
- C20H21NO
- Structure:
- Chemical Name:
- Famotidine Related Compound A Hydrochloride
- CAS:
- 76833-47-1
- MF:
- C8H15ClN6S2
- Structure:
- Chemical Name:
- Des(trifluoroethyl) Lansoprazole Sulfide
- CAS:
- 131926-97-1
- MF:
- C14H13N3OS
- Structure:
- Chemical Name:
- Desulfo Aztreonam
- CAS:
- 102579-59-9
- MF:
- C13H17N5O5S
- Structure:
- Chemical Name:
- (2S,3S,5S)-2-Hexyl-3,5-dihydroxyhexadecanoic Acid
- CAS:
- 130793-30-5
- MF:
- C22H44O4
- Structure:
- Chemical Name:
- Mosapride Citric Amide
- CAS:
- 1215825-20-9
- MF:
- C27H31ClFN3O9
- Structure:
- Chemical Name:
- (1,2,4-Triazol-4-yl) Itraconazole
- CAS:
- 854372-77-3
- MF:
- C35H38Cl2N8O4
- Structure:
- Chemical Name:
- 6,7,8,9-Tetrahydro Carvedilol
- CAS:
- 1246820-73-4
- MF:
- C24H30N2O4
- Structure:
- Chemical Name:
- Cefdinir Lactone
- CAS:
- 946573-41-7
- MF:
- C14H13N5O5S2
- Structure:
- Chemical Name:
- 5-BroModescyano CitalopraM
- CAS:
- 64169-39-7
- MF:
- C19H21BrFNO
- Structure:
- Chemical Name:
- Aripiprazole N,N-Dioxide
- CAS:
- 573691-13-1
- MF:
- C23H27Cl2N3O4
- Structure:
- Chemical Name:
- Deschloro Cetirizine Dihydrochloride
- CAS:
- 83881-54-3
- MF:
- C21H26N2O3
- Structure:
- Chemical Name:
- DesvancosaMinyl VancoMycin
- CAS:
- 101485-50-1
- MF:
- C59H62Cl2N8O22
- Structure:
- Chemical Name:
- rac N-Desbutyroyl Acebutolol
- CAS:
- 57898-80-3
- MF:
- C14H22N2O3
- Structure:
- Chemical Name:
- rac-Clopidogrel-MP Endo Derivative
- CAS:
- 1346598-12-6
- MF:
- C25H26ClNO6S
- Structure:
- Chemical Name:
- 1,1'-N-[Methylenebis(sulphanediylethylene)]bis(N'-Methyl-2-nitroethene-1,1-diaMine
- CAS:
- 1331637-48-9
- MF:
- C11H22N6O4S2
- Structure:
- Chemical Name:
- ent-LaMivudine
- CAS:
- 134680-32-3
- MF:
- C8H11N3O3S
- Structure:
- Chemical Name:
- Formoterol O-β-D-Glucuronide
- CAS:
- 615551-59-2
- MF:
- C25H32N2O10
- Structure:
- Chemical Name:
- Mono-POC Tenofovir 6-Isopropyl CarbaMate
- CAS:
- 1244022-56-7
- MF:
- C18H28N5O9P
- Structure:
- Chemical Name:
- N-Methyl Iso Desloratadine
- CAS:
- 183198-48-3
- MF:
- C20H21ClN2
- Structure:
- Chemical Name:
- Tartaric Acid Isopropyl Ester
- CAS:
- 116601-09-3
- MF:
- C7H12O6
- Structure:
- Chemical Name:
- Vardenafil Acetyl Analogue
- CAS:
- 1261351-28-3
- MF:
- C25H34N6O3
- Chemical Name:
- fenofibrate iMpurity
- Structure:
- Chemical Name:
- 2-aMino-3-Methyl-3-sulfino-4-(1H-1,2,3-triazol-1-yl)butyric acid
- CAS:
- 118175-11-4
- MF:
- C7H12N4O4S
- Structure:
- Chemical Name:
- 1,4,8,11-Tetraazacy clotetradecance, 1,4,8-tris[(4 Methylphenyl)sufonyl]-
- CAS:
- 104395-69-9
- MF:
- C31H42N4O6S3
- Structure:
- Chemical Name:
- (1S)-N-(3S)-1-Azabicyclo[2.2.2]oct-3-yl-1,2,3,4-tetrahydro-1-naphthalenecarboxaMide
- CAS:
- 177793-79-2
- MF:
- C18H24N2O
- Structure:
- Chemical Name:
- (E)-Ceftriaxone
- CAS:
- 92143-31-2
- MF:
- C18H18N8O7S3
- Structure:
- Chemical Name:
- (Z)-Cinnarizine
- CAS:
- 750512-44-8
- MF:
- C26H28N2
- Structure:
- Chemical Name:
- 6,11-Di-O-Methyl ErythroMycin
- CAS:
- 81103-14-2
- MF:
- C39H71NO13
- Structure:
- Chemical Name:
- ent-OseltaMivir Phosphate
- CAS:
- 1035895-89-6
- MF:
- C16H29N2O8P
- Structure:
- Chemical Name:
- 3,5,3',5'-Tetraiodo Thyrolactic Acid
- CAS:
- 7069-47-8
- MF:
- C15H10I4O5
- Structure:
- Chemical Name:
- 3-cyano-4-isobutoxybenzaMide
- CAS:
- 161718-85-0
- MF:
- C12H14N2O2
- Structure:
- Chemical Name:
- Caffeidinecarboxylic acid
- CAS:
- 54536-15-1
- MF:
- C8H12N4O3
- Structure:
- Chemical Name:
- 1-Keto BaMbuterol
- CAS:
- 112935-94-1
- MF:
- C18H27N3O5
- Structure:
- Chemical Name:
- 7-Chloro-4-(4-hydroxyanilino)quinoline
- CAS:
- 81099-86-7
- MF:
- C15H11ClN2O
- Structure:
- Chemical Name:
- Desfluoro EzetiMibe
- CAS:
- 302781-98-2
- MF:
- C24H22FNO3
- Structure:
- Chemical Name:
- 5-(2-Bromo-1-oxobutyl)-8-hydroxy-2(1H)-quinolinone
- CAS:
- 59827-93-9
- MF:
- C13H12BrNO3
- Structure:
- Chemical Name:
- 3-(3-TRIFLUOROMETHYL-PHENYL)-PROPYLAMINE
- CAS:
- 104774-87-0
- MF:
- C10H12F3N
- Structure:
- Chemical Name:
- 4-(3,4-Dichloro-phenyl)-3,4-dihydro-2H-naphthalen-1-one
- CAS:
- 124379-29-9
- MF:
- C16H12Cl2O
- Structure:
- Chemical Name:
- (4-(2-(azepan-1-yl)ethoxy)phenyl)Methanol
- CAS:
- 223251-16-9
- MF:
- C15H23NO2
- Structure:
- Chemical Name:
- 4-HYDROXY PROPOFOL
- CAS:
- 1988-10-9
- MF:
- C12H18O2
- Structure:
- Chemical Name:
- N1-Methylbenzene-1,2,4-triaMine
- CAS:
- 60651-29-8
- MF:
- C7H11N3
- Chemical Name:
- RocuroniuMbroMide iMpurity H
- Structure:
- Chemical Name:
- 1-[(2'-carbaMoylbiphenyl-4-yl) Methyl]-2-ethoxybenziMidazole-7-carboxylic acid
- CAS:
- 1696392-11-6
- MF:
- C24H21N3O4
- Structure:
- Chemical Name:
- 5-chloro-1-(3-diMethylaMinopropyl)-1-(4-fluorophenyl)-phthalan
- CAS:
- 64169-45-5
- MF:
- C19H21ClFNO
- Chemical Name:
- dextroMethorphanone
- Structure:
- Chemical Name:
- oxiracetaM related substance ISF3886
- CAS:
- 120428-80-0
- MF:
- C8H13N3O4
- Structure:
- Chemical Name:
- Carvedilol IMpurity D
- CAS:
- 1391052-16-6
- MF:
- C39H39N3O6
- Structure:
- Chemical Name:
- DL-2-(4-Carboxyphenyl)propionic Acid
- CAS:
- 67381-50-4
- MF:
- C10H10O4
- Structure:
- Chemical Name:
- Betamethasone 17-Propionate 21-Mesylate
- CAS:
- 15423-80-0
- MF:
- C26H35FO8S
- Structure:
- Chemical Name:
- ClarithroMycin EP IMpurity F
- CAS:
- 128940-83-0
- MF:
- C39H71NO13
- Structure:
- Chemical Name:
- 3(R)-Hydroperoxy Simvastatin
- CAS:
- 1092716-42-1
- MF:
- C25H38O7
- Structure:
- Chemical Name:
- Albendazole EP IMpurity F
- CAS:
- 80983-45-5
- MF:
- C10H11N3O2S
- Structure:
- Chemical Name:
- 10-Dehydrobaccatin V
- CAS:
- 151636-94-1
- MF:
- C29H34O10
- Structure:
- Chemical Name:
- DoxylaMine EP IMpurity A
- CAS:
- 873407-01-3
- MF:
- C17H22N2O
- Structure:
- Chemical Name:
- ((1R,3R,E)-5-((E)-2-((1R,3aS,7aR)-1-((2R,5R,E)-5,6-diMethylhept-3-en-2-yl)-7a-Methyldihydro-1H-inden-4(2H,5H,6H,7H,7aH)-ylidene)ethylidene)-4-Methylenecyclohexane-1,3-diyl)bis(oxy)bis(tert-butyldiMethylsilane)
- CAS:
- 115540-28-8
- MF:
- C40H72O2Si2
- Structure:
- Chemical Name:
- Clopidogrel EP IMpurity D
- CAS:
- 1421283-60-4
- MF:
- C24H21Cl2NO4S
- Structure:
- Chemical Name:
- Loratadine IMpurity E
- MF:
- C22H23ClN2O2
- Structure:
- Chemical Name:
- Metoprolol IMpurity E
- MF:
- C15H25NO3
- Chemical Name:
- Ceftriaxone IMpurit C
- Chemical Name:
- Flucloxacillin IMpurity G
- Structure:
- Chemical Name:
- Gefitinib N-Oxide
- CAS:
- 847949-51-3
- MF:
- C22H24ClFN4O4
- Structure:
- Chemical Name:
- Milrinone IMpurity 3
- CAS:
- 98293-81-3
- MF:
- C12H7N3O3
- Structure:
- Chemical Name:
- Nicardipine Related CoMpound 4
- CAS:
- 123973-71-7
- MF:
- C25H27N3O6
- Chemical Name:
- PraMipexole IMp.BI-II786BS
- Chemical Name:
- Propofol IMpurity E
- Chemical Name:
- Solifenacin Related CoMpound 5
- Structure:
- Chemical Name:
- TelMisartan BroMo Ethyl Ester
- CAS:
- 133085-87-7
- MF:
- C16H15BrO2