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
Butyphthalide impurity 30 Butyphthalide impurity 30
Cabozantinib impurity S Cabozantinib impurity S
Canagliflozin Isomer Impurity 1 Canagliflozin Isomer Impurity 1
Celecoxib Impurity 19 Celecoxib Impurity 19 C17H14F3N3O2S
Febuxostat Impurity 81 Febuxostat Impurity 81
Gefitinib Impurity Q Gefitinib Impurity Q
Irinotecan Impurity 20 HCl Irinotecan Impurity 20 HCl 870527-52-9 C20H20N2O4
LCZ696(valsartan + sacubitril) impurity 32 LCZ696(valsartan + sacubitril) impurity 32
Lenvatinib Impurity 25 Lenvatinib Impurity 25
Leosimendan azide Impurity Leosimendan azide Impurity
Regorafenib Impurity 23 Regorafenib Impurity 23
Regorafenib Impurity 31 Regorafenib Impurity 31
Sitafloxacin Impurity XT-D-01 Sitafloxacin Impurity XT-D-01
Sitafloxacin Impurity ZZ-E-01 Sitafloxacin Impurity ZZ-E-01
Tofacitinib Impurity 86 Tofacitinib Impurity 86
Tofacitinib Impurity 91 Tofacitinib Impurity 91
Gefitinib impurity N Gefitinib impurity N
Docetaxel Impurity 24 Docetaxel Impurity 24 1217248-58-2 C29H34O9
Olopatadine Impurity 2 Olopatadine Impurity 2 56427-76-0 C19H18O4
Pitavastatin Impurity 24 Sodium Salt Pitavastatin Impurity 24 Sodium Salt 1980814-90-1 C25H24FNO6
(3S,5S)-tert-butyl 7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate (3S,5S)-tert-butyl 7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate 1428118-12-0 C37H43FN2O5
Ibubinib impurity Ibubinib impurity
Amoxicillin EP Impurity K Amoxicillin EP Impurity K C16H19N3O5S
Amoxicillin EP Impurity C Amoxicillin EP Impurity C 2088961-37-7 C16H19N3O5S
Oseltamivir Impurity Oseltamivir Impurity 212504-89-7 C14H26N2O3
Tofacitinib Impurity QTD Tofacitinib Impurity QTD
LCZ696(valsartan + sacubitril) impurity 26 LCZ696(valsartan + sacubitril) impurity 26
Cabozantinib impurity 31 Cabozantinib impurity 31
Carvedilol Impurity COH Carvedilol Impurity COH 51997-50-3 C15H13NO2
Pregabalin Impurity 10 Pregabalin Impurity 10 69680-50-8 C7H11NO3
Butyphthalide impurity 51 Butyphthalide impurity 51
Canagliflozin Impurity 41 Canagliflozin Impurity 41
Pitavastatin Impurity 36 Pitavastatin Impurity 36
Pralatrexate Impurity 11 Pralatrexate Impurity 11
Pralatrexate Impurity 16 Pralatrexate Impurity 16
Pitavastatin Impurity 48 Pitavastatin Impurity 48
Pitavastatin Impurity 53 Pitavastatin Impurity 53
Lenvatinib Impurity 39 Lenvatinib Impurity 39 2664101-53-3
Tazobactam Impurity 10 Tazobactam Impurity 10
Crisaborole Impurity 1 Crisaborole Impurity 1
Canagliflozin Impurity 57 Canagliflozin Impurity 57
Canagliflozin Impurity 62 Canagliflozin Impurity 62
Apixaban Degradation of Impurity Apixaban Degradation of Impurity
Levetiracetam Impurity 22 Levetiracetam Impurity 22
Nifekalant Impurity 8 Nifekalant Impurity 8
Levosimendan Impurity 9 Levosimendan Impurity 9
Cabozantinib impurity J Cabozantinib impurity J
Mixture of Pemetrexed disodium EP Impurity B and C Mixture of Pemetrexed disodium EP Impurity B and C
Rotigotine Impurity 3 Rotigotine Impurity 3
Crisaborole Impurity 5 Crisaborole Impurity 5 2141947-89-7 C20H20BNO4
Crisaborole Impurity 10 Crisaborole Impurity 10
1-(3-amino-4-(benzyloxy)phenyl)-2-((1-(4-methoxyphenyl)propan-2-yl)amino)ethan-1-ol 1-(3-amino-4-(benzyloxy)phenyl)-2-((1-(4-methoxyphenyl)propan-2-yl)amino)ethan-1-ol 345288-56-4 C25H30N2O3
Olprinone Impurity 4 Olprinone Impurity 4
Ribavirin Impurity 55 Ribavirin Impurity 55 119240-35-6 C11H16O8
Cilastatin Impurity 4 Cilastatin Impurity 4
Dyclonine Impurity 3 Dyclonine Impurity 3 14146-86-2 C24H28O4
Brivaracetam Impurity F Brivaracetam Impurity F
MeropeneM iMpurity 4 MeropeneM iMpurity 4
Perindopril IMpurity 4 Perindopril IMpurity 4
Rupatadine Impurity 7 Rupatadine Impurity 7 1704730-21-1 C26H26ClN3O
ethyl 3-(dimethylamino)-2-(4-methoxyphenyl)propanoate hydrochloride ethyl 3-(dimethylamino)-2-(4-methoxyphenyl)propanoate hydrochloride 2174001-92-2 C14H22ClNO3
Flucloxacillin Impurity 3 Flucloxacillin Impurity 3
Nitrendipine iMpurity F Nitrendipine iMpurity F
Afatinib Impurity 52 Afatinib Impurity 52
Afatinib Impurity 67 Afatinib Impurity 67
Empagliflozin Impurity 60 Empagliflozin Impurity 60
Linagliptin Impurity 57 Linagliptin Impurity 57
Linagliptin Impurity 62 Linagliptin Impurity 62
Metronidazole Impurity 12 Metronidazole Impurity 12
Nintedanib Impurity 36 Nintedanib Impurity 36
Oseltamivir Impurity 47 Oseltamivir Impurity 47
Palbociclib Impurity 67 Palbociclib Impurity 67
Pimecrolimus Impurity 3 Pimecrolimus Impurity 3
Rosuvastatin Impurity 82 Rosuvastatin Impurity 82
Tenofovir Impurity 76 Tenofovir Impurity 76
Ticagrelor Impurity 125 Ticagrelor Impurity 125
Ticagrelor Impurity 39 Ticagrelor Impurity 39
Tofacitinib Impurity 109 Tofacitinib Impurity 109
Tofacitinib Impurity 114 Tofacitinib Impurity 114
Vildagliptin Impurity 34 Vildagliptin Impurity 34 1824265-77-1 C10H17NO3
1-(3-(benzyloxy)-5-hydroxyphenyl)-2-(tert-butylamino)ethan-1-one 1-(3-(benzyloxy)-5-hydroxyphenyl)-2-(tert-butylamino)ethan-1-one 2459974-72-0 C19H23NO3
Demeclocycline EP Impurity C Demeclocycline EP Impurity C 129044-45-7 C21H22N2O8
Brimonidine Impurity D Brimonidine Impurity D
Esmolol impurity D Esmolol impurity D
Diquafosol Impurity D Diquafosol Impurity D
Afatinib Impurity 10 Afatinib Impurity 10
Peramivir Impurity 11 Peramivir Impurity 11
Vildagliptin Impurity 6 Vildagliptin Impurity 6
Sunitinib Impurity 1 Sunitinib Impurity 1
Erlotinib Impurity 18 Erlotinib Impurity 18
Fasudil Impurity 6 Fasudil Impurity 6 1581642-06-9 C14H18ClN3O2S
Rosuvastatin Impurity 56 Rosuvastatin Impurity 56
Dapoxetine Impurity 4 Dapoxetine Impurity 4
Ticagrelor Impurity 17 Ticagrelor Impurity 17
Empagliflozin Impurity 13 Empagliflozin Impurity 13
Moxifloxacin Impurity 2 Moxifloxacin Impurity 2
Cabozantinib Impurity 1 Cabozantinib Impurity 1
Febuxostat Impurity 56 Febuxostat Impurity 56
Acyclovir Impurity 1 Acyclovir Impurity 1
Ambroxol Impurity 9 HCl Ambroxol Impurity 9 HCl
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