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
Palonosetron Impurity TM1-YA Palonosetron Impurity TM1-YA
Pitavastatin Impurity 33 Pitavastatin Impurity 33
Pralatrexate Impurity 14 Pralatrexate Impurity 14
Pitavastatin Impurity 51 Pitavastatin Impurity 51
Pitavastatin Impurity 59 Pitavastatin Impurity 59
Lenvatinib Impurity 42 Lenvatinib Impurity 42
Tazobactam Impurity 8 Tazobactam Impurity 8
Prednicarbate Impurity B Prednicarbate Impurity B
Doxofylline Impurity 13 Doxofylline Impurity 13
Afatinib impurity 46 Afatinib impurity 46
Canagliflozin Impurity 60 Canagliflozin Impurity 60
Canagliflozin Impurity 65 Canagliflozin Impurity 65
Rosuvastatin Impurity 75 Rosuvastatin Impurity 75
Acyclovir Impurity 11 Acyclovir Impurity 11
Selexipag Impurity 6 Selexipag Impurity 6
Cabozantinib impurity N Cabozantinib impurity N
Barcitinib impurity-09 Barcitinib impurity-09 1187594-16-6 C14H13N7
Rotigotine Impurity 6 Rotigotine Impurity 6
Olprinone Impurity 7 Olprinone Impurity 7 2236020-10-1 C9H10N2
Cilastatin Impurity 2 Cilastatin Impurity 2
Cilastatin Impurity 7 Cilastatin Impurity 7
Dabrafenib Impurity 1 Dabrafenib Impurity 1 1907654-22-1 C24H21F3N4O3S2
Eliglustat Impurity 2(Eliglustat SR-Isomer) Eliglustat Impurity 2(Eliglustat SR-Isomer) 1092472-66-6 C23H36N2O4
Tamsulosin impurity C Tamsulosin impurity C C20H28N2O5S
Umeclidinium Bromide Impurity 9 DiHCl Umeclidinium Bromide Impurity 9 DiHCl 494778-36-8 C18H32N2O4
Flucloxacillin Impurity 4 Flucloxacillin Impurity 4
Ipratropium bromide Impurity 4 Ipratropium bromide Impurity 4 C20H29Br2NO3
Cefminox Impurity 6 Cefminox Impurity 6
Afatinib Impurity 55 Afatinib Impurity 55
Apremilast Impurity 30 Apremilast Impurity 30
Aprepitant Impurity 33 Aprepitant Impurity 33 502537-39-5 C20H20F7NO3
Brivaracetam Impurity 9 Brivaracetam Impurity 9
Esomeprazole Impurity 43 Esomeprazole Impurity 43
Etoricoxib Impurity 40 Etoricoxib Impurity 40
Lenvatinib Impurity 31 Lenvatinib Impurity 31
Oseltamivir Impurity 35 Oseltamivir Impurity 35 757965-01-8 C14H22O4
Palbociclib Impurity 39 Palbociclib Impurity 39
Posaconazole Impurity 75 Posaconazole Impurity 75
Rabeprazole Impurity 22 Rabeprazole Impurity 22
Sunitinib Impurity 12 Sunitinib Impurity 12
Ticagrelor Impurity 113 Ticagrelor Impurity 113
Ticagrelor Impurity 97 Ticagrelor Impurity 97
Tofacitinib Impurity 117 Tofacitinib Impurity 117
Trelagliptin Impurity 22 Trelagliptin Impurity 22
Trelagliptin Impurity 29 Trelagliptin Impurity 29
Vildagliptin Impurity 43 Vildagliptin Impurity 43
Dexchlorpheniramine impurity F Dexchlorpheniramine impurity F
Irbesartan IMpurity F Irbesartan IMpurity F C25H28N6O
Itraconazole iMpurity 2 Itraconazole iMpurity 2
Palbociclib Impurity 6 Palbociclib Impurity 6
Azacitidine Impurity 1 Azacitidine Impurity 1
Saxagliptin Impurity 5 Saxagliptin Impurity 5
Cinacalcet Impurity 18 Cinacalcet Impurity 18
Erlotinib Impurity 23 Erlotinib Impurity 23 2021249-11-4 C23H18F6N6O
Erlotinib Impurity 36 Erlotinib Impurity 36
Fasudil Impurity 17 Fasudil Impurity 17
Febuxostat Impurity 50 Febuxostat Impurity 50
Varenicline Impurity 8 Varenicline Impurity 8
Ticagrelor Impurity 53 Ticagrelor Impurity 53
Edoxaban Impurity 5 Edoxaban Impurity 5
Edoxaban Impurity 11 Edoxaban Impurity 11
Empagliflozin Impurity 5 Empagliflozin Impurity 5 1800196-46-6 C17H16ClIO3
Carfilzomib Impurity 2 Carfilzomib Impurity 2
Oseltamivir Impurity 20 Oseltamivir Impurity 20 212504-90-0 C12H22N2O3
Febuxostat Impurity 61 Febuxostat Impurity 61
Atosiban Impurity G Atosiban Impurity G
1-cyclopropyl-6,8-dimethoxy-7-((4aS,7aS)-octahydro-6H-pyrrolo [3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic 1-cyclopropyl-6,8-dimethoxy-7-((4aS,7aS)-octahydro-6H-pyrrolo [3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic 2252446-68-5 C22H28ClN3O5
CINACALCET-001-R CINACALCET-001-R 1630761-22-6 C11H11BF4N4O
Cefotiam Impurity D Cefotiam Impurity D
Atorvastatin Calcium Hydrate impurity 39 Atorvastatin Calcium Hydrate impurity 39 2243639-97-4 C33H35FN2O5
Peramivir Impurity B Peramivir Impurity B
AztreonaM IMpurity C AztreonaM IMpurity C
Pramipexole Related Impurity 3 Pramipexole Related Impurity 3 2166216-34-6 C10H17N3OS
Lincomycin sulfoxide Impurity 5 Lincomycin sulfoxide Impurity 5
Sulpiride Impurity 4 Sulpiride Impurity 4
Tacrolimus Impurity E Tacrolimus Impurity E
Bumetanide iMpurity E Bumetanide iMpurity E
Kaempferol-3-rhamnoglucoside-7-glucoside Kaempferol-3-rhamnoglucoside-7-glucoside 34336-18-0 C33H40O20
Mupirocin iMpurity 2 Mupirocin iMpurity 2 C26H44O9
Cytarabine Impurity 10 Cytarabine Impurity 10 32830-01-6 C9H11N3O4
Ceftriaxone Sodium impurity 5 Ceftriaxone Sodium impurity 5
Sugammadex sodium Org48302 Impurity Sugammadex sodium Org48302 Impurity
176761-00-5 176761-00-5 176761-00-5 C17H15FN2O5
Pramipexole Impurity W Pramipexole Impurity W
Aprepitant Impurity 44 Aprepitant Impurity 44 172676-88-9 C23H21F7N4O3
Oseltamivir  Impurity 26 Oseltamivir Impurity 26 241465-24-7
Afatinib Impurity I Afatinib Impurity I
Moxifloxacin Impurity 5 Moxifloxacin Impurity 5
Moxifloxacin Impurity 24 Moxifloxacin Impurity 24
Fosaprepitant Impurity 1 Fosaprepitant Impurity 1
Ticagrelor Impurity 1 Ticagrelor Impurity 1
Ezetimibe Impurity 36 Ezetimibe Impurity 36
Pitavastatin Impurity 2 Pitavastatin Impurity 2
Fudosteine Impurity 2 Fudosteine Impurity 2
Sugammadex Impurity 18 Sugammadex Impurity 18
Mirabegron Impurity 21 Mirabegron Impurity 21
Apixaban Impurity 18 Apixaban Impurity 18 473927-65-0 C20H17IN4O3
Clopidogrel Impurity 12 Clopidogrel Impurity 12 C15H14ClNO2S
Oseltamivir Impurity 25 Oseltamivir Impurity 25
Ritonavir EP Impurity P Ritonavir EP Impurity P
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