Active Pharmaceutical Ingredient (API) List List Updated 03/08/2018

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Transcription:

5-Fluorouracil HPLC/ UHPLC Yes USP 4017 30 5mL 2 7-keto DHEA HPLC/ UHPLC Yes Medisca 4258 180 5mL 1 Acetaminophen HPLC/ UHPLC Yes USP 4406 5mL 2 Acetylcysteine HPLC/ UHPLC Yes USP 4255 60 5mL 1 Adenosine HPLC/ UHPLC Yes USP 4319 45 5mL 1 Alprostadil HPLC/ UHPLC Yes USP 4232 180 5mL 2 Amiodarone HCl HPLC/ UHPLC Yes USP 4335 120 5mL 1 Amiodarone HPLC/ UHPLC Yes USP 4335 120 5mL 1 Amitriptyline HCl HPLC/ UHPLC Yes USP 4269 90 5mL 1 Amitriptyline HPLC/ UHPLC Yes USP 4269 91 5mL 1 Amlodipine Besylate HPLC/ UHPLC Yes USP 4357 N/A 5mL 2 Ampicillin HPLC/ UHPLC Yes USP 4267 160 5mL 3 Anastrozole HPLC/ UHPLC Yes USP 4264 180 5mL 1 Ascorbic Acid HPLC/ UHPLC Yes USP 4350 180 5mL 2 Atropine Sulfate HPLC/ UHPLC Yes USP 4304 90 5mL 1 Atropine HPLC/ UHPLC Yes USP 4304 90 5mL 1 Baclofen HPLC/ UHPLC Yes USP 4010 180 5mL 1 Benzocaine HPLC/ UHPLC Yes USP 4328 60 5mL 1 Benzyl Alcohol HPLC/ UHPLC Yes USP 4409 5mL 2 Betamethasone (Base) HPLC/ UHPLC Yes USP 4278 90 5mL 1 Betamethasone Acetate HPLC/ UHPLC Yes USP 4202 90 5mL 2 Betamethasone Sodium Phosphate HPLC/ UHPLC Yes USP 4203 90 5mL 1 Biotin HPLC/ UHPLC Yes USP 4341 180 5mL 1 Budesonide HPLC/ UHPLC Yes USP 4385 N/A 5mL 2 Bumetanide HPLC/ UHPLC Yes USP 4201 90 5mL 1 Bupivacaine HCl HPLC/ UHPLC Yes USP 4399 90 5mL 1 Bupivacaine HPLC/ UHPLC Yes USP 4399 90 5mL 1 Buprenorphine HCl HPLC/ UHPLC Yes USP 4072 90 5mL 2 Buprenorphine HPLC/ UHPLC Yes USP 4072 90 5mL 2

Caffeine Citrate HPLC/ UHPLC Yes USP 4330 60 5mL 1 Caffeine HPLC/ UHPLC Yes USP 4330 75 5mL 1 Calcifediol HPLC/ UHPLC Needs Quote USP Calcium Chloride Dihydrate IC No USP 6001 120 5mL 3 Calcium Citrate IC No USP 6001 120 5mL 2 Calcium Gluconate Titration No Volumetric 5018 120 Nominally 2 gram of Calcium Gluconate Carbamazepine HPLC/ UHPLC Yes USP 4299 N/A 5mL 1 Cefazolin Sodium HPLC/ UHPLC Yes USP 4331 90 5mL 1 Cefazolin HPLC/ UHPLC Yes USP 4331 90 5mL 1 Cefepime HPLC/ UHPLC Yes USP 4333 90 5mL 1 Ceftazidime HPLC/ UHPLC Yes USP 4256 180 5mL 2 Ceftriaxone Sodium HPLC/ UHPLC Yes USP 4101 100 5mL 3 Ceftriaxone HPLC/ UHPLC Yes USP 4101 100 5mL 3 Cefuroxime HPLC/ UHPLC Yes USP 4300 180 5mL 1 Cefuroxime Sodium HPLC/ UHPLC Yes USP 4300 180 5mL 1 Choline Chloride IC Needs Quote Medisca 6004 180 5mL Ciprofloxacin HCl HPLC/ UHPLC Yes USP 4334 N/A 5mL 1 Ciprofloxacin HPLC/ UHPLC Yes USP 4334 N/A 5mL 1 Clindamycin Phosphate HPLC/ UHPLC Yes USP 4307 180 5mL 1 Clonidine HCl HPLC/ UHPLC Yes USP 4253 90 5mL 1 Clonidine HPLC/ UHPLC Yes USP 4253 90 5mL 1 Cyanocobalamin HPLC/ UHPLC Yes Medisca 4040 180 5mL 1 Cyclobenzaprine HCl HPLC/ UHPLC Yes USP 4249 120 5mL 1 Cyclobenzaprine HPLC/ UHPLC Yes USP 4249 120 5mL 1 Cyclopentolate HCl HPLC/ UHPLC Yes USP 4288 150 5mL 1 Dehydroepianodrosterone (DHEA) HPLC/ UHPLC Yes Medisca 4233 180 5mL 1 3

Dexamethasone Acetate HPLC/ UHPLC Yes USP 4055 90 5mL 2 Dexamethasone Sodium Phosphate HPLC/ UHPLC Yes USP 4069 90 5mL 1 Dexamethasone Phosphate HPLC/ UHPLC Yes USP 4069 90 5mL 1 Dexmedetomidine (Precedex) HPLC/ UHPLC Yes USP 4052 90 5mL 2 Dextromethorphan Hydrobromide HPLC/ UHPLC Yes USP 4282 150 5mL 2 Diazepam HPLC/ UHPLC Yes USP 4247 90 5mL 1 Diclofenac HPLC/ UHPLC Yes USP 4214 45 5mL 1 Diclofenac Potassium HPLC/ UHPLC Yes USP 4214 N/A 5mL 1 Diclofenac Sodium HPLC/ UHPLC Yes USP 4214 45 5mL 1 Diltiazem HCl HPLC/ UHPLC Yes USP 4359 90 5mL 1 Diltiazem HPLC/ UHPLC Yes USP 4359 90 5mL 1 Diphenhydramine HCl HPLC/ UHPLC Yes USP 4376 50 5mL 2 Dipyridamole HPLC/ UHPLC Yes USP 4291 60 5mL 1 Dobutamine HPLC/ UHPLC Yes USP 4270 120 5mL 1 Dopamine HCl HPLC/ UHPLC Yes USP 4393 90 5mL 1 Dopamine HPLC/ UHPLC Yes USP 4393 90 5mL 1 Doxepin HCl HPLC/ UHPLC Yes USP 4283 N/A 5mL 2 Doxepin HPLC/ UHPLC Yes USP 4283 N/A 5mL 2 Doxycycline HPLC/ UHPLC Yes USP 4420 N/A 5mL 2 Doxycycline Hyclate HPLC/ UHPLC Yes USP 4420 N/A 5mL 2 Droperidol HPLC/ UHPLC Yes USP 4329 75 5mL 1 Edetate Calcium Disodium Titration No Volumetric 5020 90 Nominally 2 gram of Edetate Calcium Disodium 2

Edetate Disodium Titration No Volumetric 5016 and 5017 180 Nominally 5 grams of Edetate Disodium Ephedrine Sulfate HPLC/ UHPLC Yes USP 4374 180 5mL 1 2 Ephedrine HPLC/ UHPLC Yes USP 4374 180 5mL 1 Epinephrine Bitartrate HPLC/ UHPLC Yes USP 4384 180 5mL 1 Epinephrine HCl HPLC/ UHPLC Yes USP 4384 180 5mL 1 Epinephrine HPLC/ UHPLC Yes USP 4384 180 5mL 1 Estradiol HPLC/ UHPLC Yes USP 4209 540 5mL 1 Estradiol Valerate HPLC/ UHPLC Yes USP 4349 180 5mL 2 Estriol HPLC/ UHPLC Yes USP 4212 180 5mL 1 Estrone HPLC/ UHPLC Yes USP 4221 180 5mL 1 * Feasibility has been confirmed and the Development is in progress, the target for completion of these methods is 2018. If you have a need for any of these actives sooner or any actives not listed, please email MarketingTechServices@dynalabs.us for Feasibility Quote or a Development Quote.

**Stability Indicating s are validated at the API level according to USP 1225 Category 1, complete with degradation studies. Validation Extension is still required for each formulation to meet the specificity requirement. For methodology that is not stability indicating due to limitations to separate degradants (e.g. IC and Titration) please contact MarketingTechServices@dynalabs.us for information about Stability Profile testing. ***Bold and Italics Stability is not confirmed. Please email MarketingTechServices@dynalabs.us for more information and for suggested storage conditions. ****For all titrations the amount of sample required is concentration based and the amount of material listed is based on the amount of active required in some cases. Please email MarketingTechServices@dynalabs.us This list is for information only; if there are any questions or concerns about the relevance of the data conveyed or the impact the information to your product please email MarketingTechServices@dynalabs.us with questions.