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
Bosutinib Impurity 7 Bosutinib Impurity 7 219786-51-3 C10H12BrNO4
Cefazolin Impurity 13 Cefazolin Impurity 13
Cefoxitin Impurity 4 Cefoxitin Impurity 4
Cilnidipine Impurity 3 Cilnidipine Impurity 3 123853-41-8 C24H22N2O6
Erlotinib Impurity 50 Erlotinib Impurity 50
Pitavastatin Impurity 26 Pitavastatin Impurity 26
Plerixafor Impurity 2 Plerixafor Impurity 2
Pregabalin Impurity 48 Pregabalin Impurity 48 1239856-83-7 C11H23NO2
Rivaroxaban Impurity 76 Rivaroxaban Impurity 76
Rocuronium bromide Impurity 36 Rocuronium bromide Impurity 36
Sildenafil Impurity 14 Sildenafil Impurity 14 2146091-79-2 C24H32N6OS2
Telmisartan Impurity 6 Telmisartan Impurity 6 1083158-65-9 C19H22N4O
Apremilast Impurity CNA Apremilast Impurity CNA
Atracurium Impurity Q Atracurium Impurity Q
Atracurium Impurity W Atracurium Impurity W
AZD9291(Osimertinib) Impurity 5 AZD9291(Osimertinib) Impurity 5
Azilsartan impurity Y Azilsartan impurity Y
Celecoxib Impurity 15 Celecoxib Impurity 15 C17H14F3N3O2S
Etoposide Impurity 2 Etoposide Impurity 2
Fludarabine EP impurity J Fludarabine EP impurity J
Ropivacaine Impurity 12 Ropivacaine Impurity 12
Solifenacin impurity 17 Solifenacin impurity 17 1029430-94-1 C19H17N3O
Sugammadex sodium Org205485-1 Impurity Sugammadex sodium Org205485-1 Impurity
Sugammadex sodium Org246653-1 Impurity Sugammadex sodium Org246653-1 Impurity
Tadalafil impurity R Tadalafil impurity R
N-((4-(5-(p-tolyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)phenyl) sulfonyl)acetamide N-((4-(5-(p-tolyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)phenyl) sulfonyl)acetamide 198471-47-5 C19H16F3N3O3S
Afatinib impurity 35 Afatinib impurity 35
Avibactam Impurity 40 Avibactam Impurity 40 2089462-89-3 C15H20N2O3
Butyphthalide impurity 29 Butyphthalide impurity 29
Butyphthalide impurity 38 Butyphthalide impurity 38 1841089-56-2 C24H30O5
Canagliflozin Impurity 39 Canagliflozin Impurity 39
Cefaclor double bond displacement impurity 9 Cefaclor double bond displacement impurity 9
Diquafosol Impurity 7 Diquafosol Impurity 7
Febuxostat Impurity 75 Febuxostat Impurity 75
Febuxostat Impurity 90 Febuxostat Impurity 90 2646683-37-4
Febuxostat Impurity 95 Febuxostat Impurity 95
Ibrutinib Impurity 17 Ibrutinib Impurity 17 2134109-10-5 C16H18N6O
LCZ696(valsartan + sacubitril) impurity 36 LCZ696(valsartan + sacubitril) impurity 36
Lenvatinib Impurity 17 Lenvatinib Impurity 17
Moxifloxacin degradation impurity 36 Moxifloxacin degradation impurity 36
Moxifloxacin Impurity 49 Moxifloxacin Impurity 49
Olsalazine Impurity B Olsalazine Impurity B
Parecoxib sodium Impurity 32 Parecoxib sodium Impurity 32
Rosuvastatin Impurity 39 Rosuvastatin Impurity 39
Tofacitinib Impurity 95 Tofacitinib Impurity 95
Vildagliptin Impurity ZA4 Vildagliptin Impurity ZA4
(E)-4-(2-(1-(m-tolyl)ethylidene)hydrazinyl)benzenesulfonamide (E)-4-(2-(1-(m-tolyl)ethylidene)hydrazinyl)benzenesulfonamide C15H17N3O2S
Fulvestrant EP Impurity E Fulvestrant EP Impurity E 2170200-14-1 C32H45F5O3S
Liquiritigenin-7-O-apiosyl(1-2)-glucoside Liquiritigenin-7-O-apiosyl(1-2)-glucoside 135432-48-3 C26H30O13
Edaravone Impurity 16 Edaravone Impurity 16
Linagliptin Impurity 50 Linagliptin Impurity 50
Landiolol impurity K Landiolol impurity K 190601-22-0 C19H29N3O6
Efinaconazole Impurity 13 Efinaconazole Impurity 13 2055038-61-2 C18H22F2N4O
Crisaborole Impurity Crisaborole Impurity 906673-42-5 C14H10BNO3
tert-butyl 2-((4R,6S)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl- 4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetate tert-butyl 2-((4R,6S)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl- 4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetate 947249-30-1 C40H47FN2O5
Olanzapine impurity N Olanzapine impurity N C17H20N4S
Cabozantinib impurity 25 Cabozantinib impurity 25
Afatinib impurity 43 Afatinib impurity 43
Vildagliptin Impurity 39 Vildagliptin Impurity 39
Tazobactam Impurity D Tazobactam Impurity D
Palonosetron Impurity 22 Palonosetron Impurity 22 1217547-14-2 C19H24N2O2
Pitavastatin Impurity 35 Pitavastatin Impurity 35
Pralatrexate Impurity 15 Pralatrexate Impurity 15
Pitavastatin Impurity 52 Pitavastatin Impurity 52
Pitavastatin Impurity 60 Pitavastatin Impurity 60 1661064-71-6 C25H22FNO3
Lenvatinib Impurity 43 Lenvatinib Impurity 43
Voriconazole Impurity 10 Voriconazole Impurity 10
Prednicarbate Impurity D Prednicarbate Impurity D
Olprinone Impurity A Olprinone Impurity A 141354-29-2 C12H10N4O
Everolimus EP Impurity E Everolimus EP Impurity E 1237826-25-3 C52H79NO14
Edaravone Impurity P4 Edaravone Impurity P4
Afatinib impurity 47 Afatinib impurity 47
Canagliflozin Impurity 50 Canagliflozin Impurity 50
Canagliflozin Impurity 66 Canagliflozin Impurity 66
Acyclovir Impurity 12 Acyclovir Impurity 12
4-(4-Hydroxy-3-hydroxymethyl-phenoxy)-benzonitrile 4-(4-Hydroxy-3-hydroxymethyl-phenoxy)-benzonitrile C14H11NO3
Cabozantinib impurity P Cabozantinib impurity P
Rotigotine Impurity 7 Rotigotine Impurity 7
Nicorandil Impurity B Nicorandil Impurity B
Cilastatin Impurity 8 Cilastatin Impurity 8
Tamsulosin impurity E Tamsulosin impurity E C20H28N2O5S
Flucloxacillin Impurity H Flucloxacillin Impurity H
Cefminox Impurity 2 Cefminox Impurity 2
Afatinib Impurity 56 Afatinib Impurity 56
Aprepitant Impurity 34 Aprepitant Impurity 34
Bosutinib Impurity 14 Bosutinib Impurity 14
Brivaracetam Impurity 16 Brivaracetam Impurity 16
Etoricoxib Impurity 41 Etoricoxib Impurity 41 855307-80-1 C18H13ClN2O2S
Fluvoxamine Impurity 10 Fluvoxamine Impurity 10
Nintedanib Impurity 50 Nintedanib Impurity 50 2410284-90-9 C56H52N8O8
Olopatadine Impurity 8 Olopatadine Impurity 8
Oseltamivir Impurity 36 Oseltamivir Impurity 36
Palbociclib Impurity 61 Palbociclib Impurity 61 2222404-53-5 C14H20N4O4
Palbociclib Impurity 41 Palbociclib Impurity 41
Saxagliptin Impurity 8 Saxagliptin Impurity 8
Tenofovir Impurity 63 Tenofovir Impurity 63
Ticagrelor Impurity 99 Ticagrelor Impurity 99
Ticagrelor Impurity 114 Ticagrelor Impurity 114
Ticagrelor Impurity 98 Ticagrelor Impurity 98
Tofacitinib Impurity 118 Tofacitinib Impurity 118
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