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.
Click on the specific product, view the latest prices of the products, information, serving information
- Structure:
- Chemical Name:
- 4-(4-Hydroxy-3-hydroxymethyl-phenoxy)-benzonitrile
- MF:
- C14H11NO3
- Chemical Name:
- Cabozantinib impurity P
- Chemical Name:
- Rotigotine Impurity 7
- Chemical Name:
- Nicorandil Impurity B
- Chemical Name:
- Cilastatin Impurity 8
- Structure:
- Chemical Name:
- Tamsulosin impurity E
- MF:
- C20H28N2O5S
- Chemical Name:
- Flucloxacillin Impurity H
- Chemical Name:
- Cefminox Impurity 2
- Chemical Name:
- Afatinib Impurity 56
- Chemical Name:
- Aprepitant Impurity 34
- Chemical Name:
- Bosutinib Impurity 14
- Chemical Name:
- Brivaracetam Impurity 16
- Structure:
- Chemical Name:
- Etoricoxib Impurity 41
- CAS:
- 855307-80-1
- MF:
- C18H13ClN2O2S
- Chemical Name:
- Fluvoxamine Impurity 10
- Structure:
- Chemical Name:
- Nintedanib Impurity 50
- CAS:
- 2410284-90-9
- MF:
- C56H52N8O8
- Chemical Name:
- Olopatadine Impurity 8
- Chemical Name:
- Oseltamivir Impurity 36
- Structure:
- Chemical Name:
- Palbociclib Impurity 61
- CAS:
- 2222404-53-5
- MF:
- C14H20N4O4
- Structure:
- Chemical Name:
- Bezafibrate Impurity D
- CAS:
- 41859-58-9
- MF:
- C21H24ClNO4
- Structure:
- Chemical Name:
- Cloxacillin Sodium EP Impurity B (Mixture of Diastereomers)
- CAS:
- 1642559-64-5
- MF:
- C18H20ClN3O4S
- Structure:
- Chemical Name:
- Ezetimibe Related Impurity 37
- CAS:
- 204589-68-4
- MF:
- C24H19F2NO2
- Chemical Name:
- Palbociclib Impurity 41
- Chemical Name:
- Saxagliptin Impurity 8
- Chemical Name:
- Tenofovir Impurity 63
- Chemical Name:
- Ticagrelor Impurity 99
- Chemical Name:
- Ticagrelor Impurity 114
- Chemical Name:
- Ticagrelor Impurity 98
- Chemical Name:
- Tofacitinib Impurity 118
- Chemical Name:
- Trelagliptin Impurity 23
- Chemical Name:
- Vildagliptin Impurity 33
- Chemical Name:
- Vildagliptin Impurity 44
- Structure:
- Chemical Name:
- Voriconazole Impurity 16
- CAS:
- 1157981-64-0
- MF:
- C10H7F2N3O
- Chemical Name:
- Itraconazole iMpurity 3
- Structure:
- Chemical Name:
- 1-(3,5-bis(benzyloxy)phenyl)-2,2-dibromoethan-1-one
- MF:
- C22H18Br2O3
- Chemical Name:
- Axitinib Impurity 8
- Chemical Name:
- Agomelatine Impurity 11
- Chemical Name:
- Saxagliptin Impurity 7
- Chemical Name:
- Cinacalcet Impurity 23
- Chemical Name:
- Erlotinib Impurity 24
- Chemical Name:
- Ticagrelor Impurity 47
- Chemical Name:
- Edaravone Impurity 10
- Chemical Name:
- Empagliflozin Impurity 10
- Chemical Name:
- Canagliflozin Impurity 10
- Chemical Name:
- Rivaroxaban Impurity 35
- Chemical Name:
- Febuxostat Impurity 67
- Structure:
- Chemical Name:
- Hydroxytyrosol 4-O-glucoside
- CAS:
- 54695-80-6
- MF:
- C14H20O8
- Chemical Name:
- Riociguat IMpurtiy A
- Chemical Name:
- Peramivir Impurity C
- Chemical Name:
- Lincomycin sulfoxide Impurity 6
- Chemical Name:
- Metronidazole IMpurity 5
- Chemical Name:
- Sulpiride Impurity 5
- Structure:
- Chemical Name:
- methyl 3-(4-(3-(ethylamino)-2-hydroxypropoxy)phenyl)propanoate hydrochloride
- MF:
- C15H24ClNO4
- Chemical Name:
- Tacrolimus Impurity F
- Chemical Name:
- Cefminox Impurity E
- Structure:
- Chemical Name:
- Palonosetron
- CAS:
- 135729-56-5
- MF:
- C19H22N2O
- Structure:
- Chemical Name:
- 4-[4-(diMethylaMino)-1-(4-fluorophenyl)-1-buten-1-yl]-3-(hydroxyMethyl)-benzonitrile (CitalopraM Olefinic IMpurity)
- CAS:
- 920282-75-3
- MF:
- C20H21FN2O
- Structure:
- Chemical Name:
- 7-Methoxy-4-oxo-1,4-dihydroquinoline-6-carboxylic acid
- CAS:
- 417721-34-7
- MF:
- C11H9NO4
- Chemical Name:
- Pemetrexed
- Structure:
- Chemical Name:
- Venlafaxine
- MF:
- C17H27NO2
- Structure:
- Chemical Name:
- (S)-4,5-dichloro-N-((2-oxo-3-(4-(3-oxoMorpholino)phenyl)oxazolidin-5-yl)Methyl)thiophene-2-carboxaMide
- CAS:
- 1770812-37-7
- MF:
- C19H17Cl2N3O5S
- Structure:
- Chemical Name:
- 2-Propen-1-one, 1-[4-[4-aMino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyriMidin-1-yl]-1-piperidinyl]-
- CAS:
- 936563-92-7
- MF:
- C25H24N6O2
- Structure:
- Chemical Name:
- 8-cyclopentyl-5-Methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)aMino)-6-vinylpyrido[2,3-d]pyriMidin-7(8H)-one
- MF:
- C24H29N7O
- Structure:
- Chemical Name:
- D-Alanine, N-[[P(R),2'R]-2'-deoxy-2'-fluoro-2'-Methyl-P-phenyl-5'-uridylyl]-, 1-Methylethyl ester
- CAS:
- 1496552-16-9
- MF:
- C22H29FN3O9P
- Structure:
- Chemical Name:
- D-Phenylalanine, N-[(1,1-diMethylethoxy)carbonyl]-L-leucyl-, Methyl ester
- CAS:
- 15136-32-0
- MF:
- C21H32N2O5
- Structure:
- Chemical Name:
- 4-Nitro-2-phenoxyphenol
- CAS:
- 70995-08-3
- MF:
- C12H9NO4
- Structure:
- Chemical Name:
- Sofosbuvir Impurity
- CAS:
- 1233335-82-4
- MF:
- C16H25FN3O9P
- Structure:
- Chemical Name:
- Ethyl 3,4-O-isopropylideneshikiMate
- CAS:
- 136994-78-0
- MF:
- C12H18O5
- Structure:
- Chemical Name:
- 4-Vinyl-piperidine-4-carboxylic acid ethyl ester
- CAS:
- 1509910-91-1
- MF:
- C10H17NO2
- Structure:
- Chemical Name:
- (2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-aMino-2-Methylpentanoic acid
- CAS:
- 1039307-95-3
- MF:
- C18H21NO2
- Chemical Name:
- EMpagliflozin iMpurity 16
- Structure:
- Chemical Name:
- ((R)-2-biphenyl-4-yl-1-forMylethyl)carbaMic acid t-butyl ester
- CAS:
- 149709-58-0
- MF:
- C20H23NO3
- Structure:
- Chemical Name:
- 1-(2,3-DiMethylphenyl)-1-(1H-iMidazol-4-yl)ethanol
- CAS:
- 86347-12-8
- MF:
- C13H16N2O
- Structure:
- Chemical Name:
- (R)-3-((R)-5-(4-fluorophenyl)-5-hydroxypentanoyl)-4-phenyloxazolidin-2-one
- CAS:
- 1612153-32-8
- MF:
- C20H20FNO4
- Structure:
- Chemical Name:
- (S)-3-((R)-5-(4-fluorophenyl)-5-hydroxypentanoyl)-4-phenyloxazolidin-2-one
- CAS:
- 528565-93-7
- MF:
- C20H20FNO4
- Chemical Name:
- Posaconazole iMpurity 3
- Structure:
- Chemical Name:
- S, R-Isovalganciclovir Impurity
- CAS:
- 1356932-18-7
- MF:
- C14H22N6O5
- Structure:
- Chemical Name:
- Sofosbuvir Impurity 8
- CAS:
- 944476-44-2
- MF:
- C24H22N2O8
- Structure:
- Chemical Name:
- 135270-13-2
- CAS:
- 135270-13-2
- MF:
- C12H11F2N3O
- Structure:
- Chemical Name:
- 1-((2'-cyanobiphenyl-4-yl)methyl)-4-methyl-2-propyl-1H-benzo[d]imidazole-6-carboxylic acid
- CAS:
- 1098100-87-8
- MF:
- C26H23N3O2
- Chemical Name:
- Fimasartan Impurity
- Structure:
- Chemical Name:
- 2-(((5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)methyl)(methyl)amino)succinic acid
- MF:
- C21H20FN3O6S
- Structure:
- Chemical Name:
- ()-Olivil 4″-O-glucoside
- CAS:
- 76880-93-8
- MF:
- C26H34O12
- Structure:
- Chemical Name:
- 2-(DIETHYLAMINO)-N-(2,4-DIMETHYLPHENYL)ACETAMIDE
- CAS:
- 17289-53-1
- MF:
- C14H22N2O
- Structure:
- Chemical Name:
- Isatin indicator solution
- MF:
- C8H5NO2
- Chemical Name:
- Oxaliplatin impurity
- Structure:
- Chemical Name:
- NiMesulide EP IMpurity
- CAS:
- 38880-53-4
- MF:
- C7H8N2O5S
- Structure:
- Chemical Name:
- Alogliptin Impurity D
- CAS:
- 1926163-25-8
- MF:
- C61H86N16O13
- Chemical Name:
- Moxifloxacin Impurities
- Structure:
- Chemical Name:
- Parecoxib Impurity K
- CAS:
- 198471-69-1
- MF:
- C17H16N2O3S
- Structure:
- Chemical Name:
- Linagliptin Impurity K
- CAS:
- 1638744-06-5
- MF:
- C25H29BrN8O2
- Structure:
- Chemical Name:
- (R)-2-((6-(3-((3-(2-cyano-5-fluorobenzyl)-1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)amino)piperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzonitrile
- CAS:
- 1917324-13-0
- MF:
- C31H28F2N8O4
- Structure:
- Chemical Name:
- L-Phenylalanine, N-[(5,7-dichloro-1,2,3,4-tetrahydro-6-isoquinolinyl)carbonyl]-3-(methylsulfonyl)-, phenylmethyl ester, hydrochloride (1:1)
- CAS:
- 1194550-65-6
- MF:
- C27H27Cl3N2O5S
- Structure:
- Chemical Name:
- Alogliptin Related Compound 23
- CAS:
- 1618644-29-3
- MF:
- C20H13ClN4O2
- Chemical Name:
- Etoricoxib Impurity 14
- Chemical Name:
- Riociguat Impurtiy 3
- Chemical Name:
- Trelagliptin Impurity 2
- Structure:
- Chemical Name:
- Chlorhexidine Impurity B
- CAS:
- 1308292-89-8
- MF:
- C16H26ClN9O
- Chemical Name:
- Dapoxetine Impurity D
- Chemical Name:
- Eltrombopag Impurity 5
- Structure:
- Chemical Name:
- Exemestane Impurity 1
- CAS:
- 159354-61-7
- MF:
- C20H24O3