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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
Saxagliptin Impurity 9 Saxagliptin Impurity 9
(1r,4r)-4-((2-aminobenzyl)amino)cyclohexanol (1r,4r)-4-((2-aminobenzyl)amino)cyclohexanol 15992-77-5 C15H22N2O5
Moxifloxacin degrade Impurity Moxifloxacin degrade Impurity
Edaravone Impurity 17 Edaravone Impurity 17
Capecitabine impurity 7 Capecitabine impurity 7
Linagliptin Impurity 46 Linagliptin Impurity 46
((3R,5S,E)-3,5-dihydroxy-7-(4-isopropyl-2-(N-methylmethylsulfonamido)-6-phenylpyrimidin-5-yl)hept-6-enoate)calcium(II) ((3R,5S,E)-3,5-dihydroxy-7-(4-isopropyl-2-(N-methylmethylsulfonamido)-6-phenylpyrimidin-5-yl)hept-6-enoate)calcium(II) C44H56CaN6O12S2
Levofloxacin Impurity 24 Levofloxacin Impurity 24 C18H20FN3O4
(trans)-2-(3,4-difluorophenyl)cyclopropanecarboxamide (trans)-2-(3,4-difluorophenyl)cyclopropanecarboxamide 1932275-13-2 C10H9F2NO
(3R,5S,Z)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6-enoic acid calcium(II) (3R,5S,Z)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6-enoic acid calcium(II) 1445208-17-2 C22H28FN3O6S
Tafluprost Impurity 7 Tafluprost Impurity 7 733036-94-7 C25H35FO5
Tropisetron Impurity 1 Tropisetron Impurity 1
Fosaprepitant Impurity DBJ Fosaprepitant Impurity DBJ
Cabozantinib impurity 29 Cabozantinib impurity 29
Cabozantinib impurity 34 Cabozantinib impurity 34
Carfilzomib Impurity YGH Carfilzomib Impurity YGH
Ondansetron Impurity 3 Ondansetron Impurity 3
Irsogladine Impurity GDT Irsogladine Impurity GDT
Cefdinan impurity S Cefdinan impurity S
(4S)-2-(((R)-2-Amino-2-phenylacetamido)(carboxy)-methyl)-5,5-dimethylthiazolidine-4-carboxylic (4S)-2-(((R)-2-Amino-2-phenylacetamido)(carboxy)-methyl)-5,5-dimethylthiazolidine-4-carboxylic 1642629-93-3 C16H21N3O5S
3,3'-(ethane-1,2-diyl)bis(1-(2-chloroethyl)-1H-benzo[d]imidazol-2(3H)-one) 3,3'-(ethane-1,2-diyl)bis(1-(2-chloroethyl)-1H-benzo[d]imidazol-2(3H)-one) 191977-79-4 C20H20Cl2N4O2
octakis(6-chloro-6-deoxy)-γ-cyclodextrin octakis(6-chloro-6-deoxy)-γ-cyclodextrin 173094-60-5 C48H72Cl8O32
N-[4-(difluoromethoxy)-2-nitrophenyl]acetamide N-[4-(difluoromethoxy)-2-nitrophenyl]acetamide 97963-75-2 C9H8F2N2O4
Ropivacaine-ET Ropivacaine-ET 2180-94-1 C16H24N2O
Pitavastatin Dihydrobenzophenanthridine Pitavastatin Dihydrobenzophenanthridine 1187966-91-1 C25H24FNO4
BDJS-SH 3 BDJS-SH 3 1817657-89-8 C12H18N2O2
Carvedilol Impurity NH Carvedilol Impurity NH
Pregabalin Impurity 8 Pregabalin Impurity 8 44996-52-3 C7H11NO3
Pregabalin Impurity 14 Pregabalin Impurity 14 1610546-44-5 C7H11NO3
Cefditoren Impurity 1 Cefditoren Impurity 1
Cefadroxil Impurity C Cefadroxil Impurity C 79962-91-7 C16H17N3O5S
Pralatrexate Impurity 8 Pralatrexate Impurity 8 112408-16-9 C8H15NO4
Pitavastatin Impurity 46 Pitavastatin Impurity 46
Canagliflozin Impurity 46 Canagliflozin Impurity 46
Lenvatinib Impurity 37 Lenvatinib Impurity 37
Sitafloxacin Impurity 20 Sitafloxacin Impurity 20
posaconazole impurity 66 posaconazole impurity 66
Dapoxetine impurity 33 Dapoxetine impurity 33
Budesonide Impurity 4 Budesonide Impurity 4
Atracurium Impurity 31 Atracurium Impurity 31
Canagliflozin Impurity 49 Canagliflozin Impurity 49 2243132-56-9 C34H35FO11S
Canagliflozin Impurity 55 Canagliflozin Impurity 55
Rosuvastatin Impurity 74 Rosuvastatin Impurity 74
Tofacitinib Impurity 106 Tofacitinib Impurity 106
Hydroxychloroquine Impurity J Hydroxychloroquine Impurity J
Levetiracetam Impurity 25 Levetiracetam Impurity 25
Levosimendan Impurity 7 Levosimendan Impurity 7
Cabozantinib impurity K Cabozantinib impurity K
Crisaborole Impurity 8 Crisaborole Impurity 8
Trifluridine Impurity B Trifluridine Impurity B
Rotigotine Impurity Rotigotine Impurity
Olprinone Impurity 2 Olprinone Impurity 2 106730-62-5 C14H12N4O2
Nicorandil Impurity F Nicorandil Impurity F
Nicorandil Impurity A Nicorandil Impurity A
Ampicillin EP Impurity N Ampicillin EP Impurity N
Apixaban Impurity 20 Apixaban Impurity 20
Aprepitant Impurity 19 Aprepitant Impurity 19 1333995-14-4
Blonanserin impurity E Blonanserin impurity E
Clindamycin Impurity 17 Clindamycin Impurity 17
Edaravone Impurity 12 Edaravone Impurity 12 2061958-41-4 C12H16N2O2
Empagliflozin Impurity 19 Empagliflozin Impurity 19
Erythromycin impurity D Erythromycin impurity D
FeBuxostat Impurity 40 FeBuxostat Impurity 40
Formoterol Impurity 13 Formoterol Impurity 13 150513-24-9 C18H24N2O3
Fosaprepitant Impurity 4 Fosaprepitant Impurity 4 1523569-85-8 C37H34F7N4O6P
Fudosteine Impurity 2 Fudosteine Impurity 2 1480319-53-6 C6H13NO5S
Ilaprazole Impurity 1 Ilaprazole Impurity 1
Ilaprazole Impurity 2 Ilaprazole Impurity 2
Isavuconazole Impurity 10 Isavuconazole Impurity 10
Isavuconazole Impurity 18 Isavuconazole Impurity 18
Isavuconazole Impurity 6 Isavuconazole Impurity 6
Lercanidipine Impurity 4 Lercanidipine Impurity 4 2727061-30-3 C18H23NO2
Nitrendipine Impurity 4 Nitrendipine Impurity 4
Olaparib Impurity 6 Olaparib Impurity 6
Paclitaxel EP Impurity H Paclitaxel EP Impurity H
Paroxetine Impurity 10 Paroxetine Impurity 10
Posaconazole Impurity 31 Posaconazole Impurity 31
Posaconazole Impurity 60 Posaconazole Impurity 60 2134652-05-2 C14H14F2O4
Regorafenib impurity D Regorafenib impurity D
SofosBuvir impurity 21 SofosBuvir impurity 21 1496552-50-1 C22H29ClN3O9P
sofosBuvir impurity 36 sofosBuvir impurity 36
SofosBuvir Impurity 52 SofosBuvir Impurity 52
SofosBuvir Impurity 59 SofosBuvir Impurity 59
Ticagrelor impurity 25 Ticagrelor impurity 25
Tirofiban Impurity 14 Tirofiban Impurity 14 1103300-75-9 C12H17NO5S
Tirofiban Impurity 19 Tirofiban Impurity 19 158808-75-4 C18H28N2O3
Amoxicillin Impurity  P Amoxicillin Impurity P C16H19N3O5S
Ampicillin Impurity S Ampicillin Impurity S
Cefdinir Impurity F (CP) Cefdinir Impurity F (CP)
Flucloxacillin Sodium Impurity A Flucloxacillin Sodium Impurity A 68728-50-7 C19H20ClFN3NaO6S
Oxacillin Sodium Impurity G(EP) Oxacillin Sodium Impurity G(EP) 724695-30-1 C19H18ClN3O5S
Spectinomycin Impurity D Spectinomycin Impurity D
(4R,4aS,5aR,12aS)-9-[2-(tert-butylamino)acetamido]-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide (4R,4aS,5aR,12aS)-9-[2-(tert-butylamino)acetamido]-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide C29H39N5O8
Amifostine Impurity 3 Amifostine Impurity 3 41510-53-6 C5H15N2O3PS
Cefradine impurity C Cefradine impurity C
Cefuroxime sodium impurity H Cefuroxime sodium impurity H C16H16N4NaO8S
Bilastine N-Oxide Bilastine N-Oxide 2069238-47-5 C28H37N3O4
Cefoxitin impurity F Cefoxitin impurity F
Tenofovir Disoproxil Fumarate impurity N Tenofovir Disoproxil Fumarate impurity N 1962114-92-6 C29H44N10O14P2
Prednisolone Impurity 7 Prednisolone Impurity 7 61549-70-0 C21H26O6
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