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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
Ezetimibe Impurity 38 Ezetimibe Impurity 38 1701462-59-0 C45H58F2N2O5Si2
Indapamide Impurity F Indapamide Impurity F 62574-66-7 C7H3Cl3O3S
Moxifloxacin Impurity 38 Moxifloxacin Impurity 38 1262758-66-6 C21H24FN3O5
Nimodipine  Impurity 3 Nimodipine Impurity 3 101072-61-1 C11H9NO5
Pitavastatin Impurity 40 Pitavastatin Impurity 40
Ritonavir EP Impurity R Ritonavir EP Impurity R
Ticagrelor Impurity 68 Ticagrelor Impurity 68 1643378-46-4 C23H29FN6O4S
Tofacitinib Impurity 70 Tofacitinib Impurity 70
Afatinib Impurity 22 Afatinib Impurity 22
Amifostine Impurity 6 Amifostine Impurity 6
Apixaban Impurity 33 Apixaban Impurity 33
Aztreonam Impurity 6 Aztreonam Impurity 6
Clarithromycin Impurity EP G Clarithromycin Impurity EP G 107216-09-1 C39H72N2O13
Dapagliflozin Impurity 32 Dapagliflozin Impurity 32
Doxofylline Impurity 7 Doxofylline Impurity 7 43135-57-5 C13H20N4O4
Erlotinib Impurity 55 Erlotinib Impurity 55
Etoposide Impurity 1 Etoposide Impurity 1
Etoposide Impurity 6 Etoposide Impurity 6
Olaparib Impurity 34 Olaparib Impurity 34 2795135-26-9
Oseltamivir Impurity 15 Oseltamivir Impurity 15 2254819-34-4 C22H36N2O4
Oseltamivir Impurity 27 Oseltamivir Impurity 27
Pitavastatin Impurity 20 Pitavastatin Impurity 20
Rocuronium Bromide Impurity 20 Rocuronium Bromide Impurity 20
Rocuronium Bromide Impurity 9 Rocuronium Bromide Impurity 9
Palbociclib Impurity 91 Palbociclib Impurity 91 571191-15-6 C22H27N7O2
Ibrutinib Impurity 28 Ibrutinib Impurity 28 2213398-75-3 C18H15N5O
Clopidogrel Impurity 60 Clopidogrel Impurity 60 1430373-12-8 C25H26ClNO6S
Ozagrel Impurity F Ozagrel Impurity F
Ceftriaxone Sodium impurity 1 Ceftriaxone Sodium impurity 1 1214622-93-1 C10H12N2O5S
Lasoprazole impurity Lasoprazole impurity
2-bromo-1-(4-chlorothiophen-2-yl)ethanone 2-bromo-1-(4-chlorothiophen-2-yl)ethanone 677007-73-7 C6H4BrClOS
951163-66-9 951163-66-9 951163-66-9 C18H17BFNO8
Fluticasone Impurity 14 Fluticasone Impurity 14 C25H31F3O5S
Ritonavir EP Impurity U Ritonavir EP Impurity U
((3R,5S)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenyl
carbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate)calcium(II)
((3R,5S)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenyl carbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate)calcium(II) C66H68CaF2N4O10
DexMedetoMidine IMpurity O DexMedetoMidine IMpurity O
Rivaroxaban Impurity 48 Rivaroxaban Impurity 48 1414932-72-1 C21H20ClN3O4
Imatinib Impurity A Imatinib Impurity A
Vonoprazan Impurity 19 Vonoprazan Impurity 19
Pregabalin Diacid Pregabalin Diacid 1788341-42-3 C16H26N2O
Dexamethasone Impurity A Dexamethasone Impurity A
Olaparib Impurity 24 Olaparib Impurity 24
Topiroxostat Impurity 6 Topiroxostat Impurity 6
Irinotecan EP Impurity H Irinotecan EP Impurity H
Teneligliptin Impurity 4 Teneligliptin Impurity 4
Erlotinib Hydrochloride iMpurity 53 Erlotinib Hydrochloride iMpurity 53
(3R,4S)-phenyl 3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4- fluorophenyl)piperidine-1-carboxylate (3R,4S)-phenyl 3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4- fluorophenyl)piperidine-1-carboxylate 2389152-22-9 C26H24FNO5
Chemtrue-RL-N5 Chemtrue-RL-N5 1589503-97-8 C26H27F2N3O6S
Moxifloxacin EP Impurity K Moxifloxacin EP Impurity K
Anestagnate Anestagnate
Trelagliptin IMpurity 33 Trelagliptin IMpurity 33
Estradiol Impurity 1 Estradiol Impurity 1 57780-81-1 C18H24O4
Metoprolol IMpurity L Metoprolol IMpurity L C15H25NO3
Teneligliptin Impurity 14 Teneligliptin Impurity 14
Verapamil Impurity N Verapamil Impurity N 2086274-75-9 C33H47N3O4
Ergoline-8-carboxylic acid, 2-bromo-9,10-didehydro-6-methyl-, (8β)- Ergoline-8-carboxylic acid, 2-bromo-9,10-didehydro-6-methyl-, (8β)- 478-83-1 C16H15BrN2O2
Adefovir Impurity 6 Adefovir Impurity 6
Apremilast Impurity QY Apremilast Impurity QY
Dextrorotation lansoprazole Impurity J Dextrorotation lansoprazole Impurity J
Dextrorotation lansoprazole-N-oxide Dextrorotation lansoprazole-N-oxide
lansoprazole Impurity 23 lansoprazole Impurity 23
lansoprazole Impurity 29 lansoprazole Impurity 29
Loratadine Impurity L Loratadine Impurity L C22H23ClN2O2
meta-dyhydroxy Sugammadex sodium Impurity 1 meta-dyhydroxy Sugammadex sodium Impurity 1
Olanzapine impurity R Olanzapine impurity R C17H20N4S
PEONIN CHLORIDE(SH) PEONIN CHLORIDE(SH) 132-37-6 C28H33ClO16
Ampicillin EP Impurity P Ampicillin EP Impurity P
5-Heptenoic acid, 7-[(1R,2R,3R,5S)-2-[(1E)-3,3-difluoro-4-phenoxy-1-buten-1-yl]-3,5-dihydroxycyclopentyl]-, 1-methylethyl ester, (5E)- 5-Heptenoic acid, 7-[(1R,2R,3R,5S)-2-[(1E)-3,3-difluoro-4-phenoxy-1-buten-1-yl]-3,5-dihydroxycyclopentyl]-, 1-methylethyl ester, (5E)- 1563176-58-8 C25H34F2O5
Butanoic acid, 2,2-dimethyl-, (1S,3R,7S,8S,8aR)-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-[(2R,4R,5S)-tetrahydro-4-hydroxy-5-methyl-6-oxo-2H-pyran-2-yl]ethyl]-1-naphthalenyl ester Butanoic acid, 2,2-dimethyl-, (1S,3R,7S,8S,8aR)-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-[(2R,4R,5S)-tetrahydro-4-hydroxy-5-methyl-6-oxo-2H-pyran-2-yl]ethyl]-1-naphthalenyl ester 477877-98-8 C26H40O5
1H-1,2,4-Triazole-1-ethanol, α-(2,4-difluorophenyl)-α-(1H-1,2,4-triazol-1-ylmethyl)-, 4-oxide 1H-1,2,4-Triazole-1-ethanol, α-(2,4-difluorophenyl)-α-(1H-1,2,4-triazol-1-ylmethyl)-, 4-oxide 1997296-62-4 C13H12F2N6O2
para-Hydroxy L-Milnacipran para-Hydroxy L-Milnacipran 688738-11-6 C15H22N2O2
Varenicline Impurity 9 Varenicline Impurity 9
Elagolix Sodium impurity3 Elagolix Sodium impurity3
Epinephrine Impurity 4 Epinephrine Impurity 4 94217-53-5 C9H13NO3
(trans)-4-((2-amino-3,6-dibromobenzyl)amino)cyclohexanol (trans)-4-((2-amino-3,6-dibromobenzyl)amino)cyclohexanol C13H18Br2N2O
Recombinant N-Acetyl Alpha-D-Glucosaminidase (NAGLU) Recombinant N-Acetyl Alpha-D-Glucosaminidase (NAGLU)
(2R,3R,4R,5R)-2-(4-amino-2-oxo (2R,3R,4R,5R)-2-(4-amino-2-oxo 1415316-72-1 C12H16N4O7
(R)-2-(3-(diisopropylamino)-1-phenylpropyl)phenol (R)-2-(3-(diisopropylamino)-1-phenylpropyl)phenol C21H29NO
Dexamethasone EP impurities F Dexamethasone EP impurities F
4-amino-1-((2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)-1,3,5-triazin-2(1H)-one compound with (2R,3S,4R,5S)-2-(hydroxymethyl)-5-methyltetrahydrofuran-3,4-diol 4-amino-1-((2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)-1,3,5-triazin-2(1H)-one compound with (2R,3S,4R,5S)-2-(hydroxymethyl)-5-methyltetrahydrofuran-3,4-diol
D-Ribofuranose, 1-C-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-2,3,5-tris-O-(phenylmethyl)- D-Ribofuranose, 1-C-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-2,3,5-tris-O-(phenylmethyl)- 1355049-94-3 C32H32N4O5
Delamanid Impurity 1 Delamanid Impurity 1
N-[4-[(6,7-Dimethoxy-4-quinolinyl)oxy]phenyl]-N'-(4-fluoro-3-hydroxyphenyl)-1,1-cyclopropanedicarboxamide N-[4-[(6,7-Dimethoxy-4-quinolinyl)oxy]phenyl]-N'-(4-fluoro-3-hydroxyphenyl)-1,1-cyclopropanedicarboxamide 1628530-41-5 C28H24FN3O6
Oseltamivir Impurity Mixture (MW:486 Da) Oseltamivir Impurity Mixture (MW:486 Da)
LANTHANUM STANDARD SOLUTION LANTHANUM STANDARD SOLUTION La
2,2'-(7-((2R,3S)-1,3,4-trihydroxybutan-2-yl)-10-((2S,3R)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecane-1,4-diyl)diacetic acid Gd3+ 2,2'-(7-((2R,3S)-1,3,4-trihydroxybutan-2-yl)-10-((2S,3R)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecane-1,4-diyl)diacetic acid Gd3+
(R)-Ethyl 3-(bromomethyl)hexanoate (R)-Ethyl 3-(bromomethyl)hexanoate 1956435-91-8 C9H17BrO2
Flucloxacillin Sodium EP Impurity B Flucloxacillin Sodium EP Impurity B
Acyclovir Impurity 15 Acyclovir Impurity 15
Brivaracetam Impurity 5 Brivaracetam Impurity 5 1942054-60-5 C7H13BrO2
(S,E)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-5-hydroxyhept-2-enoic acid calcium(II) (S,E)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-5-hydroxyhept-2-enoic acid calcium(II) 1659317-57-3 C33H35CaFN2O4
Epalrestat Impurity 4 Epalrestat Impurity 4 130786-32-2 C8H9NO3S2
Olmesartan Impurity 58 Olmesartan Impurity 58 2190488-06-1 C12H22N2O2
Apixaban Impurity 73 Apixaban Impurity 73 1998079-13-2 C44H40N8O8
Alectinib Impurity 10 Alectinib Impurity 10 1256584-81-2 C28H29N3O3
Alectinib Impurity 10 Alectinib Impurity 10 1256584-81-2 C28H29N3O3
Acemetacin Impurity C Acemetacin Impurity C
Propofol Impurity II (2,6-Diisopropyl-1,4-benzoquinone) Propofol Impurity II (2,6-Diisopropyl-1,4-benzoquinone)
Vonoprazan Impurity 58 Vonoprazan Impurity 58
Tafluprost Impurity 12 Tafluprost Impurity 12
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