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
Avatrombopag Impurity 76 Avatrombopag Impurity 76
Rosuvastatin Impurity 153 Rosuvastatin Impurity 153
Rosuvastatin Impurity 138 Rosuvastatin Impurity 138
Rosuvastatin Impurity 127 Rosuvastatin Impurity 127
4,4′-DIPHENOQUINONE (DQ) 4,4′-DIPHENOQUINONE (DQ) 494-72-4 C12H8O2
3-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]-2-[1-[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]pentan-2-yl]-1,3-diazaspiro[4.4]non-1-en-4-one 3-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]-2-[1-[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]pentan-2-yl]-1,3-diazaspiro[4.4]non-1-en-4-one 1346598-52-4 C39H38N10O
1,11-ditosyl-1,4,8,11-tetraazacyclotetradecane dihydrochloride 1,11-ditosyl-1,4,8,11-tetraazacyclotetradecane dihydrochloride 117152-73-5 C24H36N4O4S2
3,4-DICHLOROBENZYLAMINE HYDROCHLORIDE 3,4-DICHLOROBENZYLAMINE HYDROCHLORIDE 49552-34-3 C7H8Cl3N
Lenvatinib Impurity 35 Lenvatinib Impurity 35
Febuxostat Impurity 58 Febuxostat Impurity 58
Cefodizime Impurity B Cefodizime Impurity B
Cefodizime Impurity D Cefodizime Impurity D
Amlodipine Impurity 49 Amlodipine Impurity 49 79781-18-3 C18H18ClNO5
Penicillin Impurity B Penicillin Impurity B
4,4'-(1H-1,2,4-Triazol-1-ylmethylene)bis[benzoic acid] 4,4'-(1H-1,2,4-Triazol-1-ylmethylene)bis[benzoic acid] 1644566-39-1 C17H13N3O4
Cefminox Sodium impurity B Cefminox Sodium impurity B
Cefotiam Impurity B Cefotiam Impurity B
pranoprofen impurity 11 pranoprofen impurity 11 52549-44-7 C15H13NO4
Atorvastatin Calcium Hydrate impurity 32 Atorvastatin Calcium Hydrate impurity 32 2088732-01-6 C14H27NO4
Cefazolin Impurity 5 Cefazolin Impurity 5
Peramivir Impurity E Peramivir Impurity E
Lincomycin sulfoxide Impurity 3 Lincomycin sulfoxide Impurity 3
Lincomycin sulfoxide Impurity F Lincomycin sulfoxide Impurity F
Fasudil iMpurity F Fasudil iMpurity F
1-cyclopropyl-8-ethoxy-6-fluoro-7-((4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride
1-cyclopropyl-8-ethoxy-6-fluoro-7-((4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride 2252446-70-9 C22H27ClFN3O4
Doxofylline iMpurity E Doxofylline iMpurity E
Mupirocin Impurity 3 Mupirocin Impurity 3 C26H44O9
Dihydro-Simvastatin Dihydro-Simvastatin 92083-03-9 C25H40O5
Ceftriaxone Sodium impurity 3 Ceftriaxone Sodium impurity 3
Sugammadex sodium Monoiodo Impurity Sugammadex sodium Monoiodo Impurity
(3S,4R)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-1-methyl-4-phenylpiperidine (3S,4R)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-1-methyl-4-phenylpiperidine C20H23NO3
Avatrombopag Impurity 22 Avatrombopag Impurity 22 570403-14-4 C31H38Cl2N6O3S2
176760-99-9 176760-99-9 176760-99-9 C17H13FN2O4
NILOTINIB IMPURITY 17 NILOTINIB IMPURITY 17 851137-91-2 C17H15N5O
DexMedetoMidine IMpurity 16 DexMedetoMidine IMpurity 16
Canagliflozin Impurity 2 Canagliflozin Impurity 2 2952941-15-8 C18H14FIS
Rivaroxaban Impurity 22 Rivaroxaban Impurity 22
Levofloxacin Impurity 5 Levofloxacin Impurity 5 2206360-62-3 C13H10FNO5
Ezetimibe Impurity 33 Ezetimibe Impurity 33
Ezetimibe-28 Ezetimibe-28 1478663-95-4 C44H52F2N2O6Si
Vonoprazan Impurity U4 Vonoprazan Impurity U4
Emtricitabine Impurity 28 Emtricitabine Impurity 28 1238210-14-4 C8H11N3O4S
Parecoxib SodiuM iMpurity 37 Parecoxib SodiuM iMpurity 37
(3R,4R)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4-fluorophenyl)-1-methylpiperidine compound (3R,4R)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4-fluorophenyl)-1-methylpiperidine compound 105834-21-7 C20H22FNO3
Apixaban Impurity BMS-A Apixaban Impurity BMS-A
Afatinib Impurity 70 Afatinib Impurity 70 125781-04-6 C4H7ClO2
Apixaban impurity 14/6-(4-aminophenyl)-1-(4-methoxyphenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylic acid Apixaban impurity 14/6-(4-aminophenyl)-1-(4-methoxyphenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylic acid 1704504-93-7 C20H18N4O4
Cabozantinib Impurity 46 Cabozantinib Impurity 46 1247859-37-5 C11H10FNO3
Ivabradine Impurity S33172 Ivabradine Impurity S33172 2247881-26-9 C26H34N2O5
Tenofovir Impurity 71 Tenofovir Impurity 71
2-(chloromethyl)-3-methylpyridin-4-ol 2-(chloromethyl)-3-methylpyridin-4-ol 1805648-51-4 C7H8ClNO
Ampicillin EP Impurity S Ampicillin EP Impurity S
Mupirocin Calcium EP Impurity I Mupirocin Calcium EP Impurity I C26H44CaO9
Benzenepropanoic acid, α-hydroxy-β-[[(3E)-1-oxo-3-hexen-1-yl]amino]-, (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,11-dihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1H-cyclod Benzenepropanoic acid, α-hydroxy-β-[[(3E)-1-oxo-3-hexen-1-yl]amino]-, (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,11-dihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1H-cyclod 2243233-98-7 C46H55NO14
Fulvestrant impurity H Fulvestrant impurity H
Trans-5-(Benzyloxyamino)piperidine-2-carboxylic acid,sodium salt Trans-5-(Benzyloxyamino)piperidine-2-carboxylic acid,sodium salt 2122800-38-6 C13H19N2NaO3
1-(5-(2-fluorophenyl)-1-(pyridin-2-ylsulfonyl)-1H-pyrrol-3-yl)-N- methylmethanamine fumarate 1-(5-(2-fluorophenyl)-1-(pyridin-2-ylsulfonyl)-1H-pyrrol-3-yl)-N- methylmethanamine fumarate 928615-46-7 C17H16FN3O2S
2-METHYLPYRAZINE 1,4-DIOXIDE 2-METHYLPYRAZINE 1,4-DIOXIDE 32046-26-7 C5H6N2O2
4-AMINO-1-METHYL-5-PROPYL-1H-PYRAZOLE-3-CARBOXYLIC ACID AMIDE 4-AMINO-1-METHYL-5-PROPYL-1H-PYRAZOLE-3-CARBOXYLIC ACID AMIDE 247583-78-4 C8H14N4O
CAPECITABINE-D11 CAPECITABINE-D11 1132662-08-8 C15H13D11FN3O6
Bendamustine Related Impurity 2 Bendamustine Related Impurity 2
Bendamustine Related Impurity 7 Bendamustine Related Impurity 7
Bortezomib Impurity 25 Bortezomib Impurity 25
Bortezomib Impurity 40 Bortezomib Impurity 40
Edoxaban Impurity 28 (1R,2R,4R) Edoxaban Impurity 28 (1R,2R,4R) 1255529-38-4 C21H30ClN5O5
Linagliptin Impurity 31 Linagliptin Impurity 31
Olopatadine Impurity 1 Olopatadine Impurity 1 66801-40-9 C15H10O4
Paroxetine Impurity 12 Paroxetine Impurity 12
Rivaroxaban Impurity 69 DiHCl Rivaroxaban Impurity 69 DiHCl
Sitafloxacin Impurity 5 Sitafloxacin Impurity 5 1630983-99-1 C15H12ClF4NO3
Ticagrelor Related Compound 92 Ticagrelor Related Compound 92
Valsartan Impurity 10 Valsartan Impurity 10 1314799-74-0 C23H29N5O
Vonoprazan Impurity 23 Vonoprazan Impurity 23
Adefovir Impurity 1 Adefovir Impurity 1
Bendamustine Impurity G Bendamustine Impurity G
Blonanserin Impurity K Blonanserin Impurity K
Brexpiprazole Impurity F Brexpiprazole Impurity F
Cefazolin USP Impurity D Cefazolin USP Impurity D
Cefuroxime Impurity 9 Cefuroxime Impurity 9 2165460-37-5 C8H10N2O4S
Everolimus Impurity E Everolimus Impurity E
Peramivir Impurity 3 Peramivir Impurity 3
Peramivir Impurity 8 Peramivir Impurity 8
Pitavastatin Impurity 13 Pitavastatin Impurity 13
Pramipexole Impurity R Pramipexole Impurity R
Tadalafil Impuirty 21 Tadalafil Impuirty 21
Abacavir Abacavir 141271-12-7 C10H14ClN5O
Canagliflozin Impurity 42 Canagliflozin Impurity 42
Maleic Acid Maleic Acid 2170020-79-6 C21H20FN3O6S
Piperacillin Impurity N Piperacillin Impurity N
2-(1-(dimethylamino)ethyl)phenol 2,3-dihydroxysuccinate 2-(1-(dimethylamino)ethyl)phenol 2,3-dihydroxysuccinate 26050-44-2 C10H15NO
PeraMpanel PeraMpanel 684648-40-6 C10H10BNO2
3-CHLORO-N-(3-METHOXYPHENYL)PROPANAMIDE 3-CHLORO-N-(3-METHOXYPHENYL)PROPANAMIDE 21261-76-7 C10H12ClNO2
Amlodipine Impurity 31 Amlodipine Impurity 31 496024-43-2 C20H22ClNO5
Fudosteine Impurity 5 Fudosteine Impurity 5
Rasagiline Impurity 4 Rasagiline Impurity 4 1175018-79-7 C12H14ClN
D-erythro-Hexonic acid, 2,4-dideoxy-3,5-O-(1-methylethylidene)-6-S-(5-methyl-1,3,4-thiadiazol-2-yl)-6-thio-, 1,1-dimethylethyl ester D-erythro-Hexonic acid, 2,4-dideoxy-3,5-O-(1-methylethylidene)-6-S-(5-methyl-1,3,4-thiadiazol-2-yl)-6-thio-, 1,1-dimethylethyl ester 1326303-05-2 C16H26N2O4S2
L-Leucine, N-[(2S)-2-amino-1-oxo-4-phenylbutyl]- L-Leucine, N-[(2S)-2-amino-1-oxo-4-phenylbutyl]- 290298-02-1 C16H24N2O3
Glycine, N-[4-(aminocarbonyl)phenyl]- Glycine, N-[4-(aminocarbonyl)phenyl]- 355809-32-4 C9H10N2O3
5-Isobenzofurancarbonitrile, 1-[3-(dimethylamino)propyl]-1,3-dihydro-1-hydroxy- 5-Isobenzofurancarbonitrile, 1-[3-(dimethylamino)propyl]-1,3-dihydro-1-hydroxy- 2102609-59-4 C14H18N2O2
L-Milnacipran Carbamoyl-beta-D-Glucuronide L-Milnacipran Carbamoyl-beta-D-Glucuronide 1446438-98-7 C22H30N2O9
HomePage | Member Companies | Advertising | Contact us | Previous WebSite | MSDS | CAS Index | CAS DataBase
Copyright © 2016 ChemicalBook All rights reserved.