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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
Amlodipine Impurity 19 Amlodipine Impurity 19 C26H31ClN2O8S
Amlodipine Impurity 9 Amlodipine Impurity 9 90445-05-9 C26H31ClN2O8S
Clopidogrel Impurity 7 Clopidogrel Impurity 7 444728-13-6 C15H15ClN2OS
Rivaroxaban Impurity 36 Rivaroxaban Impurity 36 1770812-39-9 C19H17Cl2N3O5S
(S)-methyl 2-((2'-(2H-tetrazol-5-yl)biphenyl-4-yl)methylamino)-3-methylbutanoate (S)-methyl 2-((2'-(2H-tetrazol-5-yl)biphenyl-4-yl)methylamino)-3-methylbutanoate 1111177-24-2 C20H23N5O2
Clopidogrel Impurity C Clopidogrel Impurity C 1346605-15-9 C16H18ClNO2S
Nilotinib genotoxic impurity 2 Nilotinib genotoxic impurity 2 1157857-29-8 C19H15F3N4O3
NCFJJNFEEPMRAQ-XMMPIXPASA-N NCFJJNFEEPMRAQ-XMMPIXPASA-N 1453221-45-8 C35H41F6N3O6
Gliclazide Impurity E Gliclazide Impurity E
Ethyl 1-butanesulfonate Ethyl 1-butanesulfonate 2374-68-7 C6H14O3S
OLANEXIDINE intermediate OLANEXIDINE intermediate 60852-95-1 C10H20N4
1H-Isoindole, octahydro-, trans- 1H-Isoindole, octahydro-, trans- 10479-63-7 C8H15N
1H-Purine-2,6-dione,8-[2-(3,4-dihydroxyphenyl)ethenyl]-1,3-diethyl-3,7-dihydro-7-methyl-, (E)-(9CI) 1H-Purine-2,6-dione,8-[2-(3,4-dihydroxyphenyl)ethenyl]-1,3-diethyl-3,7-dihydro-7-methyl-, (E)-(9CI) 155272-03-0 C18H20N4O4
Hexanoicacid, 3-(2-amino-2-oxoethyl)-5-methyl-, (3S)- Hexanoicacid, 3-(2-amino-2-oxoethyl)-5-methyl-, (3S)- 181289-34-9 C9H17NO3
Ethanedioic acid, monoethyl ester, 2-(4-methoxyphenyl)hydrazide Ethanedioic acid, monoethyl ester, 2-(4-methoxyphenyl)hydrazide 2614-10-0 C11H14N2O4
4-Pyridinecarboxamide, N-[2-(nitrooxy)ethyl]-, mononitrate 4-Pyridinecarboxamide, N-[2-(nitrooxy)ethyl]-, mononitrate 65141-48-2 C8H10N4O7
1-[3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-hydroxy-pyrimidine-2,4-dione 1-[3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-hydroxy-pyrimidine-2,4-dione 69321-95-5 C9H12N2O7
2-(ACETOXYMETHYL)-4-METHOXY-3,5-DIMETHYLPYRIDINE 2-(ACETOXYMETHYL)-4-METHOXY-3,5-DIMETHYLPYRIDINE 91219-90-8 C11H15NO3
4,4'-(4H-1,2,4-TRIAZOL-4-YLMETHYLENE)BIS BENZONITRILE 4,4'-(4H-1,2,4-TRIAZOL-4-YLMETHYLENE)BIS BENZONITRILE 112809-52-6 C17H11N5
Pregna-1,4,9(11)-triene-3,20-dione,21-(acetyloxy)-17-hydroxy-6-methyl-, (6a)- Pregna-1,4,9(11)-triene-3,20-dione,21-(acetyloxy)-17-hydroxy-6-methyl-, (6a)- 93239-37-3 C24H30O5
Tadalafil EP impurity E Tadalafil EP impurity E
4'-chloro-7H-4,7'-bipyrrolo[2,3-d]pyrimidine 4'-chloro-7H-4,7'-bipyrrolo[2,3-d]pyrimidine 134965-85-8 C12H7ClN6
myricetin 3-O-β-D-xylopyranosyl(1-2)-β-D-glucopyranoside myricetin 3-O-β-D-xylopyranosyl(1-2)-β-D-glucopyranoside 142449-93-2 C26H28O17
Atracurium Impurity 26 Atracurium Impurity 26
Aztreonam Impurity 2 Aztreonam Impurity 2
Benazepril Impurity E Benazepril Impurity E C24H28N2O5
Canagliflozin Impurity 44 Canagliflozin Impurity 44
Clotrimazole Impurity 3 Clotrimazole Impurity 3
Dithio-Desethyl Carbodenafil Dithio-Desethyl Carbodenafil 1610830-81-3 C22H28N6OS2
Erlotinib Impurity 57 Erlotinib Impurity 57
Esomeprazole Impurity 41 Esomeprazole Impurity 41
Oseltamivir Impurity 29 Oseltamivir Impurity 29
Pramipexole Impurity 36 Pramipexole Impurity 36
Riboflavin Impurity 1 Riboflavin Impurity 1 64480-68-8 C16H20N2O7
Rocuronium Bromide Impurity 10 Rocuronium Bromide Impurity 10
Rocuronium Bromide Impurity 23 Rocuronium Bromide Impurity 23 C23H39NO3
Adefovir Impurity 10 Adefovir Impurity 10
Apremilast Impurity SY Apremilast Impurity SY
Atracurium Impurity L Atracurium Impurity L
Cefoxitin EP Impurity G Cefoxitin EP Impurity G
Dextrorotation lansoprazole Impurity L Dextrorotation lansoprazole Impurity L
lansoprazole Impurity 25 lansoprazole Impurity 25
Mirabegron Enantiomer Impurity Mirabegron Enantiomer Impurity
Ropivacaine Impurity 44 Ropivacaine Impurity 44
Ropivacaine Impurity 7 Ropivacaine Impurity 7
Sugammadex sodium Org199010-1 Impurity Sugammadex sodium Org199010-1 Impurity
Sugammadex sodium Org226100-1 Impurity Sugammadex sodium Org226100-1 Impurity
Afatinib impurity 32 Afatinib impurity 32
Butyphthalide impurity 26 Butyphthalide impurity 26
Butyphthalide impurity 32 Butyphthalide impurity 32
Canagliflozin Impurity 30 Canagliflozin Impurity 30
Celecoxib Impurity 20 Celecoxib Impurity 20 343853-74-7 C6H7N3O3S
Emtricitabine Impurity CFTU1 Emtricitabine Impurity CFTU1
Esomeprazole Impurity 34 Esomeprazole Impurity 34
Febuxostat Impurity 82 Febuxostat Impurity 82
Febuxostat Impurity 87 Febuxostat Impurity 87
Gefitinib Impurity R Gefitinib Impurity R
Imatinib impurity 31 Imatinib impurity 31 1356565-47-3 C17H17N7
LCZ696(valsartan + sacubitril) impurity 33 LCZ696(valsartan + sacubitril) impurity 33
Lenvatinib Impurity 26 Lenvatinib Impurity 26
Ozagrel impurity C Ozagrel impurity C
Regorafenib Impurity 24 Regorafenib Impurity 24
Regorafenib Impurity 32 Regorafenib Impurity 32
Sitafloxacin Impurity ZZ-A-01 Sitafloxacin Impurity ZZ-A-01
Solifenacin impurity 18 Solifenacin impurity 18 1243274-83-0 C14H17NO3
Tofacitinib Impurity 87 Tofacitinib Impurity 87
Tofacitinib Impurity 92 Tofacitinib Impurity 92
Amlodipine EP Impurity K Amlodipine EP Impurity K C26H31ClN2O8S
Febuxostat Impurity 49 Febuxostat Impurity 49
Budesonide Impurity 6 Budesonide Impurity 6 131918-73-5 C21H26O6
Timolol Impurity 1 Timolol Impurity 1 75014-25-4 C13H24N4O5S
Telmisartan EP-J Telmisartan EP-J 885045-90-9 C33H29ClN4O2
Pitavastatin Impurity 29 Pitavastatin Impurity 29 148516-15-8 C25H20FNO2
Rosuvastatin Related Compound 6 Rosuvastatin Related Compound 6 521973-99-9 C13H23ClO4
Medetomidine impurity Medetomidine impurity 2250243-44-6 C20H22N2O
Linagliptin Impurity 51 Linagliptin Impurity 51
Carfilzomib Impurity YGF Carfilzomib Impurity YGF
Pitavastatin Impurity 45 Pitavastatin Impurity 45 1258947-29-3 C29H32FNO4
Irinotecan Impurity L Irinotecan Impurity L
Irinotecan Impurity H Irinotecan Impurity H
LCZ696(valsartan + sacubitril) impurity 27 LCZ696(valsartan + sacubitril) impurity 27
Caspofungin Impurity EJT2 Caspofungin Impurity EJT2
Tofacitinib Impurity 100 Tofacitinib Impurity 100
Afatinib impurity 37 Afatinib impurity 37
Vildagliptin Impurity 36 Vildagliptin Impurity 36
Butyphthalide impurity 52 Butyphthalide impurity 52
Tofacitinib Impurity 102 Tofacitinib Impurity 102 1615709-90-4 C14H17ClN2
Pralatrexate Impurity 12 Pralatrexate Impurity 12 1451250-74-0 C23H23N7O5
Pralatrexate Impurity 17 Pralatrexate Impurity 17
Pitavastatin Impurity 49 Pitavastatin Impurity 49
Pitavastatin Impurity 55 Pitavastatin Impurity 55
Lenvatinib Impurity 40 Lenvatinib Impurity 40
Tazobactam Impurity 11 Tazobactam Impurity 11
Crisaborole Impurity 2 Crisaborole Impurity 2
Canagliflozin Impurity 58 Canagliflozin Impurity 58
Canagliflozin Impurity 63 Canagliflozin Impurity 63
Levetiracetam Impurity 23 Levetiracetam Impurity 23
Selexipag Impurity 4 Selexipag Impurity 4 2928611-77-0
Levosimendan Impurity 10 Levosimendan Impurity 10 134678-47-0 C11H12N2O2
Cabozantinib impurity I Cabozantinib impurity I
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