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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
Edoxaban Impurity 27 Edoxaban Impurity 27
Linagliptin Impurity 30 Linagliptin Impurity 30 2074688-81-4 C33H32N8O5
Pantoprazole Impurity 8 Pantoprazole Impurity 8
Rivaroxaban Impurity 58 Rivaroxaban Impurity 58
Rivaroxaban Impurity 65 Rivaroxaban Impurity 65
Sitafloxacin Impurity 4 Sitafloxacin Impurity 4
Ticagrelor Related Compound 83 Ticagrelor Related Compound 83
Ticagrelor Related Compound 91 Ticagrelor Related Compound 91
Vonoprazan Impurity 21 Vonoprazan Impurity 21
Ceftazidime Oxide Impurity Ceftazidime Oxide Impurity 1301254-48-7 C22H22N6O8S2
N-(2,6-dimethylphenyl)-2-(4-(2-hydroxy-3-(4-methoxyphenoxy)propyl)piperazin-1-yl)acetamide N-(2,6-dimethylphenyl)-2-(4-(2-hydroxy-3-(4-methoxyphenoxy)propyl)piperazin-1-yl)acetamide 1393717-46-8 C24H33N3O4
Atracurium Impurity 2 Atracurium Impurity 2
Blonanserin Impurity J Blonanserin Impurity J
Brexpiprazole Impurity E Brexpiprazole Impurity E
Cefazolin USP Impurity B Cefazolin USP Impurity B
Everolimus Impurity D Everolimus Impurity D
Loratadine Impurity I Loratadine Impurity I 133330-56-0 C22H21ClN2O2
Olaparib Impurity Q Olaparib Impurity Q
2-Propanone, 1,3-bis(4-methoxyphenyl)- 2-Propanone, 1,3-bis(4-methoxyphenyl)- 29903-09-1 C17H18O3
Cefathiamidine Impurity D Cefathiamidine Impurity D
Cefazolin Impurity C (EP) Cefazolin Impurity C (EP)
Cefdinir Impurity H (CP) Cefdinir Impurity H (CP)
Cefdinir Impurity S(CP) Cefdinir Impurity S(CP)
Cefodizime oxidation Impurity 1 Cefodizime oxidation Impurity 1 111874-11-4 C20H20N6O7S4
Spectinomycin Impurity F Spectinomycin Impurity F
(7S,8R)-3-[2-(tert-butylamino)acetamido]-7-[[4-carbamoyl-2-(dimethylamino)-3,5,6-trihydroxyphenyl]methyl]-6-carboxy-5,8-dihydroxy-N,N-dimethyl-4-oxo-7,8-dihydronaphthalen-1(4H)-iminium (7S,8R)-3-[2-(tert-butylamino)acetamido]-7-[[4-carbamoyl-2-(dimethylamino)-3,5,6-trihydroxyphenyl]methyl]-6-carboxy-5,8-dihydroxy-N,N-dimethyl-4-oxo-7,8-dihydronaphthalen-1(4H)-iminium C29H38N5O10+
3-pentylisobenzofuran-1(3H)-one 3-pentylisobenzofuran-1(3H)-one 111943-62-5 C13H16O2
2-[[2-2(2-Amino-4-thiazolyl)acetyl]amino]-4-thiazoleacetic Acid 2-[[2-2(2-Amino-4-thiazolyl)acetyl]amino]-4-thiazoleacetic Acid 2036283-13-1 C10H10N4O3S2
Levofloxacin Impurity 18 Levofloxacin Impurity 18 138998-47-7 C14H13F4NO3
N-(5-amino-2-methylphenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)acetamide compound with methane (1:1) N-(5-amino-2-methylphenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)acetamide compound with methane (1:1)
N-(2-methyl-5-(methylamino)phenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)formamide N-(2-methyl-5-(methylamino)phenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)formamide C18H17N5O
methyl3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin -4-yl)amino)piperidin-1-yl)-3-oxopropanoate methyl3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin -4-yl)amino)piperidin-1-yl)-3-oxopropanoate 1616761-01-3 C17H23N5O3
Labetalol iMpurity Labetalol iMpurity 2731858-23-2
(R)-methyl 2-(2-chlorophenyl)-2-((2-(thiophen-2-yl)ethyl)amino)acetate hydrochloride (R)-methyl 2-(2-chlorophenyl)-2-((2-(thiophen-2-yl)ethyl)amino)acetate hydrochloride 1258938-54-3 C15H17Cl2NO2S
TWEORVZIMOFLDE-MXTNKPTQSA-N TWEORVZIMOFLDE-MXTNKPTQSA-N 1706671-50-2 C25H31N5O9S
WGEFOIHAXGTXJE-RTMVWDMESA-N WGEFOIHAXGTXJE-RTMVWDMESA-N 1373171-12-0 C48H61NO14
ZIMIAPVHHUISPY-CLFYSBASSA-N ZIMIAPVHHUISPY-CLFYSBASSA-N 866954-86-1 C15H15F3O5
ICOFQCJKJOISKD-HSZRJFAPSA-N ICOFQCJKJOISKD-HSZRJFAPSA-N 1435768-96-9 C26H35NO3
DIHYDROCYCLOSPORIN A DIHYDROCYCLOSPORIN A 59865-15-5 C62H113N11O12
Moxidectin Moxidectin 119718-45-5 C37H53NO8
GDZISNMJFAJFMR-BEQCQUFHSA-M GDZISNMJFAJFMR-BEQCQUFHSA-M 2024603-92-5 C58H74N2O15S
GJXNGCFWGJQETE-UHFFFAOYSA-N GJXNGCFWGJQETE-UHFFFAOYSA-N 1796891-27-4 C29H34N6O4
ethyl N-[(2,5-dichlorophenyl)carbonyl]glycinate ethyl N-[(2,5-dichlorophenyl)carbonyl]glycinate 328283-61-0 C11H11Cl2NO3
Irbesartan Impurity 4 Irbesartan Impurity 4 945540-26-1 C21H20N6O
BAUCJPGULMYPTE-UHFFFAOYSA-N BAUCJPGULMYPTE-UHFFFAOYSA-N 2097683-67-3 C24H29NO4
Brivaracetam-d7 Brivaracetam-d7 1202896-51-2 C11H20N2O2
Entecavir Impurity 6 Entecavir Impurity 6 1354695-82-1 C26H27N5O3
Bis(L-Valine) Ester Ganciclovir TFA Salt Bis(L-Valine) Ester Ganciclovir TFA Salt 130914-71-5 C19H31N7O6
Ozagrel Impurity 3 Ozagrel Impurity 3
Pitavastatin Impurity 12 Pitavastatin Impurity 12
(6S,7S)-2-amino-6-(propylamino)-4,5,6,7-tetrahydro-1,3-benzothiazol-7-ol (6S,7S)-2-amino-6-(propylamino)-4,5,6,7-tetrahydro-1,3-benzothiazol-7-ol
Melphalan EP impurity H Melphalan EP impurity H 88457-23-2 C14H20Cl2N2O2
ethyl 2-(4-(sec-butoxy)-3-formylphenyl)-4-methylthiazole-5-
carboxylate ethyl 2-(4-(sec-butoxy)-3-formylphenyl)-4-methylthiazole-5- carboxylate 2375033-31-9 C18H21NO4S
Canagliflozin Impurity 33 Canagliflozin Impurity 33
Loratadine Impurity 14 Loratadine Impurity 14 169253-13-8 C22H23ClN2O2
Metronidazole Impurity 3 Metronidazole Impurity 3 5006-79-1 C6H7N3O2
Nifedipine Impurity 9 Nifedipine Impurity 9 87625-92-1 C15H15NO5
Peramivir Impurity 7 HCl Peramivir Impurity 7 HCl 1352062-19-1 C14H27ClN2O4
Butylphthalide impurity Butylphthalide impurity 380905-48-6 C12H16O3
Dapoxetine impurity Dapoxetine impurity 2242008-38-2 C30H32ClNO2
Esomeprazole Impurity 26 Esomeprazole Impurity 26 704910-88-3 C15H15N3OS
Pregabalin Impurity 25 Pregabalin Impurity 25
Loxoprofen Loxoprofen 50882-18-3 C7H10O3
Ropivacaine impurity Ropivacaine impurity 1543937-58-1 C13H16N2O3
Mono Oxidation Sugammadex(Org198958-2) Mono Oxidation Sugammadex(Org198958-2) 2412953-13-8 C72H113NaO49S8
3,3'-(oxybis(ethane-1,1-diyl))bis(1,2-dimethylbenzene) 3,3'-(oxybis(ethane-1,1-diyl))bis(1,2-dimethylbenzene) C20H26O
Piperacillin Impurity 4 Piperacillin Impurity 4
(R)-3-amino-4-phenyl-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4] triazolo[4,3-a]pyrazin-7(8H)-yl)butan-1-one (R)-3-amino-4-phenyl-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4] triazolo[4,3-a]pyrazin-7(8H)-yl)butan-1-one 2749805-70-5 C16H18F3N5O
Amlodipine Impurity 30 Amlodipine Impurity 30 95574-97-3 C4H7ClO3
Axitinib Impurity 24 Axitinib Impurity 24
Rasagiline Impurity 3 Rasagiline Impurity 3 1175018-74-2 C12H14ClN
(+/-)-EPINEPHRINE SULFONIC ACID (+/-)-EPINEPHRINE SULFONIC ACID 26405-77-6 C9H13NO5S
4-tert-Butyl-N-(6-chloro-5-(2-methoxyphenoxy)-2,2'-bipyrimidin-4-yl)benzenesulfonamide 4-tert-Butyl-N-(6-chloro-5-(2-methoxyphenoxy)-2,2'-bipyrimidin-4-yl)benzenesulfonamide 150727-06-3 C25H24ClN5O4S
(S)-2-(BENZYLOXY)PROPIONAL (S)-2-(BENZYLOXY)PROPIONAL 81445-44-5 C10H12O2
1-Chloro-2-[(4-ethoxyphenyl)methyl]benzene 1-Chloro-2-[(4-ethoxyphenyl)methyl]benzene 1662702-90-0 C15H15ClO
Mupirocin iMpurity F Mupirocin iMpurity F C26H44O9
Palbociclib Impurity 87 Palbociclib Impurity 87 571189-51-0 C25H31N7O2
Beclometasone Impurity U Beclometasone Impurity U
Atracurium Impurity 15 Iodide(Cisatracurium Besilate EP Impurity O Iodide) Atracurium Impurity 15 Iodide(Cisatracurium Besilate EP Impurity O Iodide) 155913-31-8 C38H49NO11S
Vortioxetine Impurity 29 Vortioxetine Impurity 29 1928741-88-1 C18H23ClN2S
Neratinib Impurity 12 Neratinib Impurity 12 544417-27-8 C33H37ClN6O3
Ceftriaxone Sodium impurity 2 Ceftriaxone Sodium impurity 2
Enrofloxacin EP Impurity E Enrofloxacin EP Impurity E 1369495-59-9 C19H22ClN3O3
147027-08-5 147027-08-5 147027-08-5 C14H24O4S
Cloxacillin EP Impurity A Cloxacillin EP Impurity A 1642629-96-6 C19H20ClN3O6S
Entacapone Impurity 7 Entacapone Impurity 7 1215039-66-9 C12H10N2O6
1,8-dibenzyl-1,4,8,11-tetraazacyclotetradecane tetrahydrochloride 1,8-dibenzyl-1,4,8,11-tetraazacyclotetradecane tetrahydrochloride 267241-20-3 C24H37ClN4
(3S,3'S,4R,4'R)-3,3'-(oxybis(methylene))bis(4-(4-fluorophenyl)-1- methylpiperidine) (3S,3'S,4R,4'R)-3,3'-(oxybis(methylene))bis(4-(4-fluorophenyl)-1- methylpiperidine) C26H34F2N2O
DexMedetoMidine IMpurity 15 DexMedetoMidine IMpurity 15
Canagliflozin Impurity 1 Canagliflozin Impurity 1
Vonoprazan Impurity 24 Vonoprazan Impurity 24
Esomeprazole Impurity Esomeprazole Impurity
Esomeprazole Impurity 27 Esomeprazole Impurity 27
Amlodipine Impurity 30 Amlodipine Impurity 30 1089674-39-4 C26H31ClN2O8S
Alogliptin Impurity 30 Alogliptin Impurity 30
Orlistat Impurity 16 Orlistat Impurity 16
Olaparib Impurity 27 Olaparib Impurity 27
Hydrocortisone Impurity 14 Hydrocortisone Impurity 14 C21H30O5
Teneligliptin Impurity 5 Teneligliptin Impurity 5
Erlotinib Hydrochloride iMpurity 54 Erlotinib Hydrochloride iMpurity 54
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