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 CAS MF
Apixaban Amino Acid Impurity Apixaban Amino Acid Impurity 2206825-87-6 C25H27N5O5
Bortezomib Impurity 52 Bortezomib Impurity 52 87304-47-0 C15H26BClO2
Moxifloxacin Impurity 20 HCl Moxifloxacin Impurity 20 HCl 959347-97-8 C21H25N3O4
2-amino-3,5-dibromo-N-((1r,4r)-4-hydroxycyclohexyl)benzamide 2-amino-3,5-dibromo-N-((1r,4r)-4-hydroxycyclohexyl)benzamide 105735-86-2 C13H16Br2N2O2
Palonosetron Impurity TM1-RR Palonosetron Impurity TM1-RR 1022895-91-5 C15H23ClN2
Eltrombopag Impurity 6 Eltrombopag Impurity 6
(1r,4r)-4-((2-amino-3-bromobenzyl)amino)cyclohexanol hydrochloride (1r,4r)-4-((2-amino-3-bromobenzyl)amino)cyclohexanol hydrochloride C13H20BrClN2O
(1s,4s)-4-((2-amino-5-bromobenzyl)amino)cyclohexanol hydrochloride (1s,4s)-4-((2-amino-5-bromobenzyl)amino)cyclohexanol hydrochloride 5579-35-1 C13H20BrClN2O
Moxifloxacin oxide Impurity Moxifloxacin oxide Impurity
Edaravone Impurity 18 Edaravone Impurity 18
Linagliptin Impurity 47 Linagliptin Impurity 47
(3R,5S,E)-7-(4-(4-fluorophenyl)-2-((2-hydroxy-N,2-dimethylpropyl)sulfonamido)-6-isopropylpyrimidin-5-yl)-3,5-dihydroxyhept-6-enoic acid (3R,5S,E)-7-(4-(4-fluorophenyl)-2-((2-hydroxy-N,2-dimethylpropyl)sulfonamido)-6-isopropylpyrimidin-5-yl)-3,5-dihydroxyhept-6-enoic acid 1715120-13-0 C25H34FN3O7S
Cabozantinib impurity 28 Cabozantinib impurity 28
Cabozantinib impurity 33 Cabozantinib impurity 33
Ondansetron Impurity 2 Ondansetron Impurity 2
Rivaroxaban Degradation Impurity C Rivaroxaban Degradation Impurity C
Irsogladine Impurity DQJ Irsogladine Impurity DQJ 61382-84-1 C9H6Cl2N4O
Pregabalin Impurity 7 Pregabalin Impurity 7 70767-77-0 C8H13NO3
Pregabalin Impurity 13 Pregabalin Impurity 13 1089315-68-3 C7H11NO3
Pralatrexate Impurity 7 Pralatrexate Impurity 7
Pitavastatin Impurity 39 Pitavastatin Impurity 39
Dapoxetine impurity 31 Dapoxetine impurity 31
Lenvatinib Impurity 36 Lenvatinib Impurity 36
Sitafloxacin Impurity 19 Sitafloxacin Impurity 19
Febuxostat Impurity 97 Febuxostat Impurity 97
Dapoxetine impurity 32 Dapoxetine impurity 32
Olprinone Impurity D Olprinone Impurity D
Atracurium Impurity 30 Atracurium Impurity 30
Canagliflozin Impurity 48 Canagliflozin Impurity 48
Canagliflozin Impurity 54 Canagliflozin Impurity 54
Atracurium Impurity 33 Atracurium Impurity 33
Tofacitinib Impurity 105 Tofacitinib Impurity 105
Cabozantinib impurity Q Cabozantinib impurity Q
Gadobutrol Impurity 1 Gadobutrol Impurity 1 216670-14-3 C22H42ClLiN4O6
Pemetrexed disodium EP Impurity B Pemetrexed disodium EP Impurity B
Crisaborole Impurity 7 Crisaborole Impurity 7
Valnemulin EP Impurity A Valnemulin EP Impurity A 1624614-06-7 C31H52N2O6S
Olprinone Impurity F Olprinone Impurity F
Nicorandil Impurity E Nicorandil Impurity E
Prednicarbate Impurity G Prednicarbate Impurity G
Anastrozole iMpurity F Anastrozole iMpurity F
Ondansetron IMpurity 6 Ondansetron IMpurity 6
MeropeneM iMpurity 6 MeropeneM iMpurity 6
Macitentan Impurity 33 Macitentan Impurity 33 2089065-77-8 C28H32Br2N8O6S2
Cefminox Impurity 5 Cefminox Impurity 5
Alogliptin Impurity 27 Alogliptin Impurity 27
Alogliptin Impurity 20 Alogliptin Impurity 20
Cyclobenzaprine Impurity 3 Cyclobenzaprine Impurity 3 24167-44-0 C15H11BrO
Emtricitabine Impurity 16 Emtricitabine Impurity 16 1160303-44-5 C8H10FN3O4S
Etoricoxib Impurity 44 Etoricoxib Impurity 44
Irbesartan Impurity 15 Irbesartan Impurity 15 C25H28N6O
Linagliptin Impurity 54 Linagliptin Impurity 54
Ornidazole Impurity 13 Ornidazole Impurity 13 1685275-23-3 C7H10N3O6P.Na
Oseltamivir Impurity 44 Oseltamivir Impurity 44
7-Hydroxy Alosetron 7-Hydroxy Alosetron 863485-44-3 C17H18N4O2
Dolutegravir 2-Desfluoro Impurity Dolutegravir 2-Desfluoro Impurity 1863916-88-4 C20H20FN3O5
Moxifloxacin Impurity 46 Moxifloxacin Impurity 46 1932499-97-2 C8H16N2
Posaconazole Impurity 43 Posaconazole Impurity 43 1428118-40-4 C13H20N2O2
Empagliflozin Impurity 32 Empagliflozin Impurity 32 1620758-25-9 C24H29ClO8
Sugammadex Impurity 16 Sugammadex Impurity 16 2412952-97-5 C69H108BrNaO46S7
1,1'-(1,4,8,11-tetraazacyclotetradecane-1,11-diyl)bis(2,2,2- trifluoroethan-1-one) dihydrochloride 1,1'-(1,4,8,11-tetraazacyclotetradecane-1,11-diyl)bis(2,2,2- trifluoroethan-1-one) dihydrochloride C14H24Cl2F6N4O2
9-fluoro-6,7-dihydro-5-methyl-1-oxo-8-(4-oxo-1,2,3,4-tetrahydro-1-pyridyl)-1H,5H-benzo[i,j]quinolizine-2-carboxylic acid 9-fluoro-6,7-dihydro-5-methyl-1-oxo-8-(4-oxo-1,2,3,4-tetrahydro-1-pyridyl)-1H,5H-benzo[i,j]quinolizine-2-carboxylic acid 130539-72-9 C19H17FN2O4
Clopidogrel Clopidogrel 444728-15-8 C15H15ClN2OS
(3R,5S)-5-((S)-8-fluoro-4-isopropyl-2-(N-methylmethyl sulfonamido)-5,6-dihydrobenzo[h]quinazolin-6-yl)-3,5- dihydroxypentanoate calcium(II) (3R,5S)-5-((S)-8-fluoro-4-isopropyl-2-(N-methylmethyl sulfonamido)-5,6-dihydrobenzo[h]quinazolin-6-yl)-3,5- dihydroxypentanoate calcium(II) 854898-50-3 C44H54CaF2N6O12S2
Oseltamivir Impurity 51 Oseltamivir Impurity 51
Palbociclib Impurity 47 Palbociclib Impurity 47
Rosuvastatin Impurity 98 Rosuvastatin Impurity 98
Sildenafil Impurity 38 Sildenafil Impurity 38 C22H30N6O4S
Tenofovir Impurity 70 Tenofovir Impurity 70
Ticagrelor Impurity 122 Ticagrelor Impurity 122
Tofacitinib Impurity 111 Tofacitinib Impurity 111 2374700-37-3 C27H31N5O2S
Trelagliptin Impurity 41 Trelagliptin Impurity 41
Carbocistein Impurity D Carbocistein Impurity D
Ranitidine impurity F Ranitidine impurity F C13H22N4O3S
Beclometasone Impurity B Beclometasone Impurity B
(3R)-Nmethyl-3-(3-methylphenoxy)-3-phenylpropan-1-amine (3R)-Nmethyl-3-(3-methylphenoxy)-3-phenylpropan-1-amine 1643684-05-2 C17H22ClNO
Caspofungin Impurity 6 Caspofungin Impurity 6
Erythromycin Impurity 3 Erythromycin Impurity 3 1357466-70-6 C38H69N3O13S
Itraconazole iMpurity 6 Itraconazole iMpurity 6
Ribavirin API  Impurity O Ribavirin API Impurity O 799-87-1 C13H11N2O8P
Aprepitant Impurity 14 Aprepitant Impurity 14
Trelagliptin Impurity 16 Trelagliptin Impurity 16
Decitabine Impurity 7 Decitabine Impurity 7
Fosaprepitant Impurity 6 Fosaprepitant Impurity 6
Dapoxetine Impurity 6 Dapoxetine Impurity 6
Regorafenib Impurity 13 Regorafenib Impurity 13
Topiroxostat Impurity 4 Topiroxostat Impurity 4
Bosutinib Impurity 8 Bosutinib Impurity 8
Ticagrelor Impurity 13 Ticagrelor Impurity 13
Ticagrelor Impurity 66 Ticagrelor Impurity 66
Canagliflozin Impurity 8 Canagliflozin Impurity 8
Canagliflozin Impurity 16 Canagliflozin Impurity 16
Oseltamivir Impurity 12 Oseltamivir Impurity 12
Oseltamivir Impurity 32 Oseltamivir Impurity 32
Riociguat IMpurtiy E Riociguat IMpurtiy E
Meropenem impurity diastereomer 2 Meropenem impurity diastereomer 2 96035-15-3 C15H19N3O5S
Clindamycin Impurity A Clindamycin Impurity A
Tigecycline Impurity F Tigecycline Impurity F
Fasudil iMpurity A Fasudil iMpurity A
Cefminox Impurity C Cefminox Impurity C
HomePage | Member Companies | Advertising | Contact us | Previous WebSite | MSDS | CAS Index | CAS DataBase
Copyright © 2016 ChemicalBook All rights reserved.