TABLE VII

Buffers and pH Adjusting Agents

ExcipientpH RangeExample
Acetate
    Sodium2.5–7.0Syntocinon® (Novartis)
    Acetic acid2.5–7.2Syntocinon® (Novartis)
    Glacial acetic acid3.5–7.0Brevibloc® (Ohmeda)
    Ammonium6.8–7.8Bumex Injection® (Roche)
Ammonium sulfate-Innovar® (Astra)
Ammonium hydroxide-Triostat® (Jones Medical)
Arginine7.0–7.4Retavase® (Boehringer)
Aspartic acid5.0–5.6Pepcid® (Merck)
Benzene sulfonic acid3.25–3.65Nimbex® (Glaxo Wellcome)
Benzoate sodium/acid3.5–6.9Valium® (Roche)
Bicarbonate, sodium5.5–11.0Cenolate® (Abbott)
Boric acid/sodiumComvax® (Merck)
Carbonate, sodium4.0–11.0Hyperab® (Bayer)
Carbon dioxide-Serentil® (Boehringer) used to fill headspace
Citrate
    Acid2.5–9.0DTIC-Dome® (Bayer)
    Sodium3.0–8.5Amikin® (Bristol Myers)
    Disodium6.1Cerezyme® (Genzyme)
    Trisodium6.1Cerezyme® (Genzyme)
Diethanolamine9.5–10.5Bactim IV® (Roche)
Glucono delta lactone5.5–7.0Quinidine Gluconate (Lilly)
Glycine/glycine HCl2.5–10.8Hep-B Gammagee® (Merck)
Histidine/histidine HCl5.0–6.5Doxil® (Sequus)
Hydrochloric acidBroad rangeAmicar® (Immunex)
Hydrobromic acid3.5–6.5Scopolamine (UDL)
Lactate sodium/acid2.7–5.8Innovar® (Janssen)
Lysine (L)-Eminase® (Roberts)
Maleic acid3.0–5.0Librium® (Roche)
Meglumine6.5–11.0Magnevist® (Berlex)
Methanesulfonic acid3.2–4.0DHE-45® (Novartis)
Monoethanolamine8.0–9.0Terramycin (Pfizer)
Phosphate
    Acid6.5–8.5Saizen® (Serono Labs)
    Monobasic potassium6.7–7.3Zantac® (Glaxo-Wellcome)
    Dibasic potassium6.7–7.3Aminosyn® (Hospira)
    Monobasic sodium*2.5–8.0Pregnyl® (Organon)
    Dibasic sodium**2.5–8.3Zantac® (Glaxo-Wellcome)
    Tribasic sodium-Synthroid® (Knoll)
Sodium hydroxideBroad rangeOptiray® (Mallinckrodt)
Succinate sodium/disodium5.0–6.0AmBisome® (Fujisawa)
Sulfuric acid3.0–7.0Nebcin® (Lilly)
Tartrate sodium/acid2.5–6.2Methergine® (Novartis)
Tromethamine (Tris)6.5–9.0Optiray® (Mallinckrodt)

  • ↵* Sodium biphosphate, sodium dihydrogen phosphate, or Na dihydrogen orthophosphate.

  • ↵** Sodium phosphate, disodium hydrogen phosphate.