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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 CAS MF
1-(6-chloro-5-fluoropyrimidin-4-yl)ethanol 1-(6-chloro-5-fluoropyrimidin-4-yl)ethanol 1289559-76-7 C6H6ClFN2O
Fluoxetine Impurity 29,methyl({3-phenyl-3-[2-(trifluoromethyl)phenoxy]propyl})amine Fluoxetine Impurity 29,methyl({3-phenyl-3-[2-(trifluoromethyl)phenoxy]propyl})amine 56161-71-8 C17H18F3NO
(Z)-4-chloro-6-(3-(2,4-difluorophenyl)-4-(1H-1,2,4-triazol-1-yl)but-3-en-2-yl)-5-fluoropyrimidine (Z)-4-chloro-6-(3-(2,4-difluorophenyl)-4-(1H-1,2,4-triazol-1-yl)but-3-en-2-yl)-5-fluoropyrimidine
Ceftriaxone sodium impurity 09 Ceftriaxone sodium impurity 09
Cefradine Impurity 8 Cefradine Impurity 8 30959-67-2 C16H19N3O4S
Dobutamine Impurity 3 Dobutamine Impurity 3 334947-75-0 C19H25NO3
Anastrozole Impurity 19 Anastrozole Impurity 19 1301724-97-9 C19H21N3O2
Biotin Impurity Biotin Impurity 171232-73-8 C19H18N2O2S
Varenicline Impurity 1 Varenicline Impurity 1
Amlodipine Impurity 27 Disodium Salt Amlodipine Impurity 27 Disodium Salt 120289-11-4 C19H20ClNO7
Erlotinib Impurity 47 HCl Erlotinib Impurity 47 HCl
Etoricoxib Impurity 33 Etoricoxib Impurity 33
2,2-dichloro-N-(2,3-dimethylphenyl)acetamide 2,2-dichloro-N-(2,3-dimethylphenyl)acetamide 18823-63-7 C10H11Cl2NO
METHYL TRIPHENYLMETHYL ETHER METHYL TRIPHENYLMETHYL ETHER 596-31-6 C20H18O
2-(1-HydroxyCyclohexyl)-2-(4-MethoxyPhenyl)Acetonitrile 2-(1-HydroxyCyclohexyl)-2-(4-MethoxyPhenyl)Acetonitrile 93413-76-4 C15H19NO2
4,5-Dibromo-1,2-benzenediol 4,5-Dibromo-1,2-benzenediol 2563-26-0 C6H4Br2O2
CLOPIDOGREL CARBOXYLIC ACID CLOPIDOGREL CARBOXYLIC ACID 144457-28-3 C15H14ClNO2S
RAC (CIS/TRANS) DONEPEZIL N-OXIDE RAC (CIS/TRANS) DONEPEZIL N-OXIDE 120013-84-5 C24H29NO4
5-Carboxy-2'-deoxyuridine 5-Carboxy-2'-deoxyuridine 14599-46-3 C10H12N2O7
BENZENE ACETIC ACID, 4-[(2-CARBOXYPHENYL)METHOXY] BENZENE ACETIC ACID, 4-[(2-CARBOXYPHENYL)METHOXY] 55453-89-9 C16H14O5
Ipragliflozin Impurity 5 Ipragliflozin Impurity 5
Alectinib Impurity Alectinib Impurity 1256584-83-4 C26H25N3O2
Afatinib impurity 11/Des-(4-dimethylamino-2-en-1-oxo)butylamino 6-(5-Hydroxy-pyrrolidin-2-on-1-yl) Afatinib Afatinib impurity 11/Des-(4-dimethylamino-2-en-1-oxo)butylamino 6-(5-Hydroxy-pyrrolidin-2-on-1-yl) Afatinib 2223677-58-3 C22H20ClFN4O4
Ibrutinib Impurity 18 Ibrutinib Impurity 18 1881246-01-0 C16H12N4O
Vitamin B1 Impurity 6 Vitamin B1 Impurity 6 C12H17ClN4OS
5,5'-((tert-butylazanediyl)bis(1-hydroxyethane-2,1-diyl))bis(benzene- 1,3-diol) 5,5'-((tert-butylazanediyl)bis(1-hydroxyethane-2,1-diyl))bis(benzene- 1,3-diol) C20H27NO6
2,2'-difluoro-3,3'-dimethoxy-1,1'-biphenyl 2,2'-difluoro-3,3'-dimethoxy-1,1'-biphenyl 2316733-82-9 C14H12F2O2
nicergoline impurity N nicergoline impurity N
Clopidogrel Impurity 50 Clopidogrel Impurity 50 C15H14ClNO2S
PraMipexole IMpurity Z1/Z2 PraMipexole IMpurity Z1/Z2
trans-Ibuprofen Impurity G trans-Ibuprofen Impurity G C13H18O2
Vonoprazan Impurity 15 Vonoprazan Impurity 15
Esomeprazole Impurity 6 Esomeprazole Impurity 6
Erlotinib Impurity 22 Erlotinib Impurity 22
Teneligliptin Impurity 1 Teneligliptin Impurity 1
Erlotinib Hydrochloride iMpurity 51 Erlotinib Hydrochloride iMpurity 51
(S)-10-(1-aminocyclopropyl)-3-methyl-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid formic acid (S)-10-(1-aminocyclopropyl)-3-methyl-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid formic acid C17H18N2O6
1H-Imidazole-1-ethanol, α-(chloromethyl)-5-nitro- 1H-Imidazole-1-ethanol, α-(chloromethyl)-5-nitro- 116989-52-7 C6H8ClN3O3
4-Pyridinemethanol, 3-hydroxy-2,5-dimethyl-, hydrochloride (1:1) 4-Pyridinemethanol, 3-hydroxy-2,5-dimethyl-, hydrochloride (1:1) 875-26-3 C8H11NO2.ClH
Afatinib ImpurityOYQ Afatinib ImpurityOYQ
Androst-3-en-17-one,(5) Androst-3-en-17-one,(5) 14935-81-0 C19H28O
Landiolol impurity X Landiolol impurity X
2-((4-(3-aminopiperidin-1-yl) 2-((4-(3-aminopiperidin-1-yl)
Rosuvastatin Impurity 111 Rosuvastatin Impurity 111
ERYTHROMYCIN IMPURITY N ERYTHROMYCIN IMPURITY N
Fesoterodine Impurity 12 Fesoterodine Impurity 12
Dexamethasone EP impurities D Dexamethasone EP impurities D
Palbociclib impurity LMAP Palbociclib impurity LMAP
(3R,3'R)-3,3'-((((S)-1-amino-1-oxobutan-2-yl)azanediyl)bis(methylene))dihexanoic acid (3R,3'R)-3,3'-((((S)-1-amino-1-oxobutan-2-yl)azanediyl)bis(methylene))dihexanoic acid C18H34N2O5
Acetaminophen EP Impurity L Acetaminophen EP Impurity L C8H9NO2
Anagrelide Impurity 2 HCl Anagrelide Impurity 2 HCl
Mizolastine Impurity N Mizolastine Impurity N 108612-60-8 C25H27FN6O
(R)-4-(2-(benzyl(methyl)amino)-1-hydroxyethyl)benzene-1,2-diol (R)-4-(2-(benzyl(methyl)amino)-1-hydroxyethyl)benzene-1,2-diol 317351-40-9 C16H19NO3
N,N'-Bis(4-hydroxyphenyl)hydrazine N,N'-Bis(4-hydroxyphenyl)hydrazine 158905-63-6 C12H12N2O2
13-Cis Vitamin A Palmitate 13-Cis Vitamin A Palmitate 26771-20-0 C36H60O2
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
Metoprolol IMpurity V Metoprolol IMpurity V C15H25NO3
Teneligliptin Impurity 12 Teneligliptin Impurity 12
Nicergoline EP Impurity E Nicergoline EP Impurity E
Hexanoic acid, 3-[(hydroxyamino)methyl]-5-methyl-, (3S)- Hexanoic acid, 3-[(hydroxyamino)methyl]-5-methyl-, (3S)- 2349671-57-2 C8H17NO3
α-D-Glucopyranoside, methyl 1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, 2,3,4,6-tetraacetate α-D-Glucopyranoside, methyl 1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, 2,3,4,6-tetraacetate 714269-58-6 C30H35ClO11
Caspofungin Impurity H Caspofungin Impurity H
(trans)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4-methoxyphenyl)-1-methylpiperidine hydrochloride (trans)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4-methoxyphenyl)-1-methylpiperidine hydrochloride 127017-41-8 C21H26ClNO4
Ezetimibe Impurity 76 Ezetimibe Impurity 76 1185883-46-8 C39H44F2N2O5Si
Cefmetazole impurity 9/(6R-cis)-7-[[[(Cyanomethyl)thio]acetyl]amino]-3-(hydroxymethyl)-7-methoxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Cefmetazole impurity 9/(6R-cis)-7-[[[(Cyanomethyl)thio]acetyl]amino]-3-(hydroxymethyl)-7-methoxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid 70953-19-4 C13H15N3O6S2
((cis)-4-(4-fluorophenyl)-1-methylpiperidin-3-yl)methyl 4-methylbenzenesulfonate ((cis)-4-(4-fluorophenyl)-1-methylpiperidin-3-yl)methyl 4-methylbenzenesulfonate C20H24FNO3S
Elagolix Sodium impurity1 Elagolix Sodium impurity1
Ibrutinib Impurity 37 Ibrutinib Impurity 37 330793-49-2 C10H13IN6
(S)-((6-(propylamino)-4,5,6,7-tetrahydrobenzo[d]thiazol-2-yl)amino)methanol (S)-((6-(propylamino)-4,5,6,7-tetrahydrobenzo[d]thiazol-2-yl)amino)methanol C11H19N3OS
(trans)-4-((6-amino-2,3-dibromobenzyl)amino)cyclohexanol (trans)-4-((6-amino-2,3-dibromobenzyl)amino)cyclohexanol C13H18Br2N2O
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