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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
Ceftriaxone Sodium impurity 4 Ceftriaxone Sodium impurity 4
Sugammadex sodium Hepta-Iodine Impurity Sugammadex sodium Hepta-Iodine Impurity
Abitrone project impurity Abitrone project impurity
105981-34-8 105981-34-8 105981-34-8 C15H22N4S
1364671-52-2 1364671-52-2 1364671-52-2 C19H19ClN6O3S
1627504-43-1 1627504-43-1 1627504-43-1 C14H14ClN7
Pramipexole Impurity Q Pramipexole Impurity Q
Aprepitant Impurity 42 Aprepitant Impurity 42 172678-47-6 C20H18F7NO2
Efinaconazole Related Impurity 13 Efinaconazole Related Impurity 13 2055912-03-1 C24H32FN5O
DexMedetoMidine IMpurity 17 DexMedetoMidine IMpurity 17
Sofosbuvir IMpurity 21 Sofosbuvir IMpurity 21 2138483-01-7 C17H17FN2O6
Moxifloxacin Impurity 1 Moxifloxacin Impurity 1
Moxifloxacin Impurity 22 Moxifloxacin Impurity 22
Linagliptin Impurity F Linagliptin Impurity F
Trelagliptin Impurity 4 Trelagliptin Impurity 4
Fudosteine Impurity 1 Fudosteine Impurity 1
Sugammadex Impurity 17 Sugammadex Impurity 17 2414905-36-3 C82H120NaO48PS7
Apixaban Impurity 28 Apixaban Impurity 28 2208275-54-9
Apremilast Impurity TNB Apremilast Impurity TNB
Atracurium Impurity N Atracurium Impurity N
Avibactam Impurity X Avibactam Impurity X
Cefazolin Impurity L Cefazolin Impurity L
Ceftazidime hetero trans oxidation Impurity Ceftazidime hetero trans oxidation Impurity
Regorafenib Impurity 17 Regorafenib Impurity 17
Ropivacaine Impurity 45 Ropivacaine Impurity 45 2726971-51-1
Sildenafil Impurity 17 Sildenafil Impurity 17 C22H30N6O4S
Sugammadex sodium Org199074-1 Impurity Sugammadex sodium Org199074-1 Impurity
Sugammadex sodium Org238832-1 Impurity Sugammadex sodium Org238832-1 Impurity
Afatinib impurity 33 Afatinib impurity 33
Avibactam Impurity 38 Avibactam Impurity 38 2241730-86-7 C20H29BrN2O5
Butyphthalide impurity 27 Butyphthalide impurity 27 33704-16-4 C12H12O5
Butyphthalide impurity 35 Butyphthalide impurity 35
Canagliflozin Impurity 31 Canagliflozin Impurity 31
Celecoxib Impurity 21 Celecoxib Impurity 21 2055787-31-8 C17H12F3N3O3S
Emtricitabine Impurity CFTU2 Emtricitabine Impurity CFTU2
Febuxostat Impurity 88 Febuxostat Impurity 88
Gefitinib Impurity S Gefitinib Impurity S
Ibrutinib Impurity 15 Ibrutinib Impurity 15 1288338-97-5 C47H46N12O3
LCZ696(valsartan + sacubitril) impurity 34 LCZ696(valsartan + sacubitril) impurity 34
Lenvatinib Impurity 27 Lenvatinib Impurity 27
Montelukast sodium impurity H Montelukast sodium impurity H
Regorafenib Impurity 25 Regorafenib Impurity 25
Fluvastatin EP Impurity E Fluvastatin EP Impurity E C24H26FNO4
Oseltamivir Impurity 24 Oseltamivir Impurity 24
(3S,3'S,4R,4'R)-diphenyl 3,3'-(oxybis(methylene))bis(4-(4- fluorophenyl)piperidine-1-carboxylate) (3S,3'S,4R,4'R)-diphenyl 3,3'-(oxybis(methylene))bis(4-(4- fluorophenyl)piperidine-1-carboxylate) C38H38F2N2O5
Nettopitan impurity Nettopitan impurity
Afatinib Impurity 74 Afatinib Impurity 74 1259015-90-1 C7H13NO2
Afatinib Impurity 74 Afatinib Impurity 74 1259015-90-1 C7H13NO2
Afatinib Impurity 78 Afatinib Impurity 78
Afatinib Impurity 78 Afatinib Impurity 78
Cabozantinib Impurity 47 Cabozantinib Impurity 47 113136-79-1 C11H10ClNO3
Landiolol impurity Q Landiolol impurity Q
Tenofovir Impurity 72 Tenofovir Impurity 72
Medetomidine Impurity 52 Medetomidine Impurity 52 128366-51-8 C13H14N2O2
Regorafenib Impurity 33 Regorafenib Impurity 33
Sitafloxacin Impurity ZZ-A-02 Sitafloxacin Impurity ZZ-A-02
Solifenacin impurity 19 Solifenacin impurity 19 1422505-78-9 C17H17NO
Tofacitinib Impurity 93 Tofacitinib Impurity 93
Topiroxostat Impurity 30 Topiroxostat Impurity 30
Sitafloxacin Impurity 8 Sitafloxacin Impurity 8
Budesonide Impurity 7 Budesonide Impurity 7 3949-79-9 C23H28O7
Azacitidine Impurity 34 Azacitidine Impurity 34 105330-94-7 C9H14N4O5
Diazepam Impurity 1 Diazepam Impurity 1 36020-94-7 C16H15ClN2O2
Rosuvastatin Related Compound 8 Rosuvastatin Related Compound 8 521974-01-6 C13H23ClO4
1-benzyl-4-hydroxy-2-methyl-1H-benzo[d]imidazole-6-carboxylic acid 1-benzyl-4-hydroxy-2-methyl-1H-benzo[d]imidazole-6-carboxylic acid 1640981-19-6 C16H14N2O3
Apixaban Impurity 24 Apixaban Impurity 24 2264018-89-3 C25H26N4O6
ammonium 1-(5-methoxy-1H-benzo[d]imidazol-2-yl)-3,5-dimethyl-4-oxo-1,4-dihydropyridine-2-carboxylate ammonium 1-(5-methoxy-1H-benzo[d]imidazol-2-yl)-3,5-dimethyl-4-oxo-1,4-dihydropyridine-2-carboxylate 2227107-89-1 C16H18N4O4
Aztreonam Impurity 8 Aztreonam Impurity 8
(1s,4s)-4-((2-amino-4-bromobenzyl)amino)cyclohexan-1-ol hydrochloride (1s,4s)-4-((2-amino-4-bromobenzyl)amino)cyclohexan-1-ol hydrochloride C13H20BrClN2O
Pitavastatin Impurity 18 Sodium Salt Pitavastatin Impurity 18 Sodium Salt 2276678-27-2 C25H25FNNaO5
Moxifloxacin Impurity 67 Moxifloxacin Impurity 67 1430075-14-1 C10H16ClNO3
Landiolol impurity Landiolol impurity
Irinotecan Impurity K Irinotecan Impurity K
Palbociclib  Impurity 28 Palbociclib Impurity 28
Afatinib impurity 40 Afatinib impurity 40
Vildagliptin Impurity 37 Vildagliptin Impurity 37
Tazobactam Impurity B Tazobactam Impurity B 115546-66-2 C10H12N4O5S
Brexpiprazole Impurity 20 Brexpiprazole Impurity 20 105685-34-5 C12H14N2O
Pralatrexate Impurity 13 Pralatrexate Impurity 13
Pralatrexate Impurity 18 Pralatrexate Impurity 18
Pitavastatin Impurity 50 Pitavastatin Impurity 50
Pitavastatin Impurity 58 Pitavastatin Impurity 58
Lenvatinib Impurity 41 Lenvatinib Impurity 41
Tazobactam Impurity 12 Tazobactam Impurity 12
Tofacitinib Impurity 103 Tofacitinib Impurity 103
Posaconazole impurity 69 Posaconazole impurity 69
Crisaborole Impurity 3 Crisaborole Impurity 3
Canagliflozin Impurity 59 Canagliflozin Impurity 59
Canagliflozin Impurity 64 Canagliflozin Impurity 64
Hydroxychloroquine Impurity I Hydroxychloroquine Impurity I
Sitafloxacin Impurity 22 Sitafloxacin Impurity 22
Levetiracetam Impurity 24 Levetiracetam Impurity 24
Selexipag Impurity 5 Selexipag Impurity 5 2928611-79-2 C22H23N3O3
Levosimendan Impurity 11 Levosimendan Impurity 11
Cabozantinib impurity O Cabozantinib impurity O
(41S,12S,13aS)-12-(ethoxycarbonyl)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydroindolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine 4(1H)-oxide (41S,12S,13aS)-12-(ethoxycarbonyl)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydroindolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine 4(1H)-oxide 52341-36-3 C22H28N2O4
Rotigotine Impurity 5 Rotigotine Impurity 5
Rotigotine Impurity 10 Rotigotine Impurity 10
(S)-2-cyclopentyl-2-hydroxy-2-phenylacetic acid (S)-2-cyclopentyl-2-hydroxy-2-phenylacetic acid 64471-43-8 C13H16O3
Olprinone Impurity 6 Olprinone Impurity 6
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